tricento transcatheter tricuspid valved stent graft
TRANSCRIPT
INSTRUCTIONS FOR USE
TRICENTO
Transcatheter Tricuspid Valved Stent Graft
Implantation System
Custom made Device
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Copyright
All rights reserved. No part of this publication may be duplicated, adapted or translated without
prior written permission, except within the framework of the copyright laws.
© Copyright NVT GmbH
Subject to technical modification
Illustrations and technical specifications may vary slightly from those in this document as a
result of ongoing product development.
Manufacturer
NVT GmbH
Lotzenäcker 17
72379 Hechingen
GERMANY
Phone: +49 (0) 7471 98979-0
Fax: +49 (0) 7471 98979-222
www.nvt-med.com
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USED SYMBOLS AND SIGNIFICATION
Patient number
Do not re-use
Date of manufacture
Attention, observe the accompanying documents
Observe the instructions for use
Manufacturer
Sterile using aseptic processing techniques
Sterilization with ethylene oxide
Do not use if package is damaged
Temperature limitation (10°C to 38°C)
Keep away from sunlight
Keep dry
Qty. # Quantity included in package
Do not resterilize
MR conditional
Medical Device
Contains biological material of animal origin
Transport and store upright
Fragile
Warm temperature indicator: Do not use if indicator is black
Cold temperature indicator: Do not use if indicator is purple
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TABLE OF CONTENTS
Used symbols and signification ............................................................................................. 3
Table of Contents .................................................................................................................. 4
1. Short description of the device ..................................................................................... 5
2. Brief description of the implantation process ................................................................ 6
3. Indication ...................................................................................................................... 6
4. Contraindication ........................................................................................................... 7
5. Warnings ...................................................................................................................... 8
6. Precautions .................................................................................................................. 9
7. Potential complications Risks and side effects ............................................................11
8. Directions for use ........................................................................................................12
8.1 Physician training ........................................................................................................12
8.2 Required equipment ....................................................................................................12
8.3 Required material ........................................................................................................12
8.4 Inspection prior to use .................................................................................................13
8.5 Patient screening and Bioprosthesis sizing .................................................................13
8.6 Patient screening and procedural planning ..................................................................14
8.7 Tricento Delivery System handling and preparation .....................................................14
8.8 Bioprosthesis rinsing procedure ..................................................................................15
8.9 Loading procedure ......................................................................................................15
8.10 Delivery system flushing ..............................................................................................16
8.11 Bioprosthesis delivery .................................................................................................16
8.12 Bioprosthesis deployment ...........................................................................................17
8.13 Withdrawal of the Delivery System ..............................................................................18
8.14 Verification of prosthetic valve position and measurements .........................................19
9. How supplied ...............................................................................................................19
9.1 Available sizes ............................................................................................................19
9.2 Packaging ...................................................................................................................19
9.3 Storage .......................................................................................................................20
10. MRI safety information ................................................................................................20
11. Information on the materials and substances to which the patient can be exposed .....21
12. Patient information ......................................................................................................22
13. Training .......................................................................................................................22
14. Reporting to manufacturer and competent authority ....................................................23
15. Performance characteristics of the device and the specification of clinical benefits to be
expected .....................................................................................................................23
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This document describes warnings, recommendations and tips and tricks
specific to the application of the TRICENTO Valved Stent Graft System.
Implantation of the TRICENTO Valved Stent Graft Bioprosthesis may only be
performed by physicians who have received an appropriate training.
1. SHORT DESCRIPTION OF THE DEVICE
The TRICENTO Tricuspid Valved Stent Graft Implantation System (TTVI System) from NVT
GmbH was developed for the treatment of severe tricuspid regurgitation.
The conventional treatment of patients with severe tricuspid regurgitation is a highly invasive
surgical procedure (traditional open heart surgery with the aim of tricuspid valve repair or
tricuspid valve replacement) which is often no possible option for the affected patients.
The TRICENTO system is a gentle, minimally invasive, catheter-based treatment alternative
for patients for whom surgical treatment is out of the question and who cannot be adequately
treated with drug therapies alone.
The TRICENTO system consists of a custom-made Valved Stent Graft Delivery System
(Delivery System), a custom-made Valved Stent Graft Bioprosthesis (Bioprosthesis) and a
Loading System.
The Bioprosthesis is self-expandable and consists of a stent graft spanning from the inferior
to the superior vena cava and a lateral bicuspid valve element, both made out of porcine
pericardium and Nitinol support structures. It is positioned within the right atrium and prevents
backflow into the venous system (in this case the vena cava inferior and superior). Anchoring
is achieved by oversizing the stent elements in the area of overlap of stent and caval veins.
This overlapping area also functions as a sealing zone that prevents blood from flowing back
into the upper and lower vena cava during systole.
The Delivery System is based on a 24 Fr stent graft catheter and it is suitable for being
introduced into the venous system under standardized techniques via a transfemoral venous
access (with or without sheath). It is equipped with several key element and features that
enables the prosthesis to be advanced atraumatically to the desired implantation site (vena
cava/ right atrium) and then to be released/implanted in a controlled and safe manner.
The Delivery System and Bioprosthesis are both outfitted with radiopaque landmarks. A
marker band at the cartridge of the Delivery System provides a reference to the current step
of the deployment process, markers on the bioprosthesis helping to find the correct
implantation position.
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The Loading System consists of a Loading Funnel which helps to load the Bioprosthesis into
the Delivery System in a controlled and non-destructive way.
2. BRIEF DESCRIPTION OF THE IMPLANTATION PROCESS
The Bioprosthesis is loaded into the Delivery System, utilizing the Loading System. The
Delivery system is then introduced into the femoral vein and advanced to the implantation site
at the right atrium and neighboring caval veins. Deployment of the Bioprosthesis starts in the
vena cava superior. The retaining sheath is retracted by actuating the handle of the “Squeeze
to Release” mechanism of the Delivery System handle. Repeated actuation of the handle will
further retract the sheath/catheter and allow for expansion of the Bioprosthesis. After the
superior caval vein segment is released, continuing the retracting movement the lateral valve
element is expanded inside the atrial cavity and becomes functional. The inferior caval vein
segment is released after removing the safety locker element and thus confirming the final
release. After confirmation of a satisfactory implant position the Bioprosthesis is completely
released and the Delivery System is closed and retrieved from the patient.
3. INDICATION
The TRICENTO system is indicated for patients suffering from severe symptomatic tricuspid
regurgitation with systolic backflow in the caval and hepatic veins.
Delivery System TRICENTO
Bioprosthesis
Loading System
(Accessory)
TTVI System
Valve Element Stent Graft
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4. CONTRAINDICATION
The Valved Stent Graft Bioprosthesis is not to be used if the implanting physician believes
its implantation is contrary to the best interest of the patient
There should be no other medical device in the implantation area of the TRICENTO that
could interfere with the proper deployment of the prosthesis or its function (for example:
dialysis catheter, central venous catheter or pacemaker electrodes). If such a device is
present in a patient and cannot be removed, a decision must be made in each individual
case as to whether TRICENTO implantation is still possible.
Echocardiographic evidence of intracardiac thrombus or vegetation
Femoral veins which preclude safe placement of a 26 Fr introducer sheath or direct
sheathless placement of the 24 Fr Valved Stent Graft Delivery System
Patient unsuitable for implantation because of thrombosis of the lower venous system
Patient with a vena cava filter
Tricuspid valve stenosis
Evidence of active endocarditis or other acute infections
Known hypersensitivity to
contrast media, which cannot be adequately pre-medicated
Nitinol (Titanium or Nickel) alloy
Porcine tissue
Gold
Contraindication to anticoagulant or anti-platelet medication (aspirin, heparin, warfarin or
clopidogrel)
Systolic Pulmonary Artery Pressure (sPAP) > 50 mmHg
Pulmonary Vascular Resistance > 3 Wood units
Peak Right Atrial Pressure > 25 mmHg
Patients present severe right atrium dilatation (mega atrium) precluding safe implant
deployment and fixation
Bleeding diathesis or coagulopathy
Thrombophilia
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5. WARNINGS
Each Bioprosthesis and Delivery System is built up as a custom made, single use device
with dimensions specified by the implanting physician to suit the anatomy of an individual
patient. All components may only be used once for the treatment of this individual patient
Reuse is not possible because the system cannot be resterilized or adapted to the
changed geometries of another patient
The usability oriented development process and risk management process applied during
the design of the Bioprosthesis and Delivery System reduce the inherent risks of the
procedure and failure modes of the devices. No final statement can be made about the
clinical performance of each custom made device specified by the implanting physician
This procedure should only be performed where emergency cardiac surgery can be
performed promptly
Correct implantation height of the Bioprosthesis is essential to prevent interferences with
the hepatic veins and ensure proper anchoring
Correct sizing of the Bioprosthesis is essential to prevent paraprosthetic leak (endoleak),
migration or vessel rupture. The Bioprosthesis is intended for use in candidates with
diameters of the vena cava inferior and superior ranging from 16 mm to 35 mm
Do not resterilize or re-use the Bioprosthesis, Delivery System or Loading System.
Resterilization or re-use may compromise the structural integrity of the products and/or
create a risk of contamination of the device, which could result in patient injury, illness or
death
Accelerated deterioration due to calcific degeneration of the Bioprosthesis (as with any
glutaraldehyde cross-linked prosthesis) may occur in patients with an altered calcium
metabolism
Overall durability, especially long-term, has not been established for the Valved Stent Graft
Bioprosthesis. Careful and continuous medical follow-up is advised so that Bioprosthesis-
related complications can be diagnosed and properly managed
The adequate frequency of the medical follow-up examinations should be determined by
the treating physician taking into account the individual state of health of the patient
It is recommended that all Valved Stent Graft Bioprosthesis recipients be treated with
antibiotics to minimize the possibility of bioprosthetic valve infection (endocarditis)
Bioprosthetic valve recipients should be maintained on anticoagulant therapy
Do not freeze. Always store the Bioprosthesis in a cool, dry place. Any Bioprosthesis that
has been frozen must not be used for human implantation
Do not perform an implantation without a guidewire
Physicians without previous experience using the Valved Stent Graft System shall be
trained by NVT personnel prior to the procedure
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In patients with previously placed pacemaker leads, the stability, location and course of
the leads must be considered when planning the implantation. A pacemaker lead in the
superior vena cava (SVC) does not contra-indicate the implantation of the Valved Stent
Graft Bioprosthesis, especially when it lies directly at the wall and is fixed. However in
cases where interference with the Bioprosthesis or tension on the lead after implantation
can be expected, the Valved Stent Graft Bioprosthesis should not be implanted
Use the Delivery System only if the ETO indicator on the inner sterile bag is green
Do not use if the integrity of the sterile packaging has been compromised
In the event of any non-matching information, do not use the product
Do not use the Bioprosthesis if the product jar is damaged or if the seal is broken or the
outside of the product jar is wet
Do not use the Bioprosthesis if there are any signs of damage
Do not use the Delivery System if there are any signs of damage
Do not use the Bioprosthesis if the warm temperature indicator is black or the cold
temperature indicator’s bulb is purple
Loading of the Valved Stent Graft Bioprosthesis into the Delivery System must only be
performed utilizing the dedicated Loading System
Only certified personnel may perform the loading procedure
Patients with an implanted ICD (Implantable Cardioverter Defibrillator) have to evaluated
with special carefulness. Possible interactions between Bioprosthesis and ICD have to be
considered
Patients with severely impaired ventricles should not be treated with TRICENTO
Patients with worse than moderately impaired right ventricle (as evidenced by low values
of TAPSE, Velocity Time Integral, right ventricular systolic myocardial velocity S’ or
comparable parameters) should not be treated with TRICENTO
6. PRECAUTIONS
Before using the products, check the temperature indicators, the ETO indicator, and the
compliance of the patient number by four-eye principle
The outside of the product jar is not sterile and must not enter the sterile field
Follow aseptic techniques during device preparation and implantation
Any Bioprosthesis that is dropped, damaged, or mishandled in any way must not be used
for implantation
Do not handle or manipulate the Bioprosthesis with sharp or pointed objects
Do not squeeze the Bioprosthesis during rinsing. No other objects should be placed in the
rinsing bowls
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Ensure not to rinse the Bioprosthesis in an already used rinsing solution
Avoid too many crimping cycles during loading
After loading check if the safety locker is placed
If you feel any resistance during loading, the loading procedure must be stopped and the
cause of the resistance has to be evaluated
Do not kink the Delivery System
Make sure, that if you pre-bend the guidewire, it will not be damaged
Before introducing the Delivery System into the patient, check visually the correct loading
of the Bioprosthesis
If you feel any resistance introducing the Delivery System, the procedure must be stopped
and the cause of the resistance has to be evaluated
Fix the Delivery System stably once positioned at the desired implantation site in order to
avoid any change
Before removal of the Delivery System check if the Bioprosthesis is entirely released from
the Delivery System
The Delivery System closure is recommended to be performed in the vena cava inferior,
below the implanted Bioprosthesis
During Delivery Catheter Shaft closure do not force the catheter against the tip to avoid
overlapping. If this occurs the diameter of the tip will be increased by the overlapping
catheter and make it difficult to withdraw the Delivery System
If a correct placement of the prosthesis is not possible for any reason or if the implantation
creates an unforeseen danger for the patient, the implantation must be aborted
If any malfunction occurs during implantation, the resulting risk for the patient must be
assessed and the implantation must be discontinued if the safety of the patient is impaired
Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or
repeated exposure or inhalation of the solution. Use only with adequate ventilation. If skin
contact occurs, immediately flush the affected area with water. In the event of contact with
eyes, seek immediate medical attention.
Make sure to flush all flushing ports with sterile saline solution until no more air bubbles
are visible when holding the tip under solution and flushing. Generously flush the
integrated sheath via the flushing port.
Anticoagulation therapy should follow the recommendations from the ESC/EACTS
guidelines.
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7. POTENTIAL COMPLICATIONS RISKS AND SIDE EFFECTS
Potential complications, risks and side effects that may be associated with the use of the
Valved Stent Graft System include, but may not be limited to:
Allergic reactions/intolerances (e.g. to contrast media)
Arrhythmias including tachycardia or fibrillation extending to cardiac arrest
Conduction disorders
Bleeding (hemorrhage)
Cardiac tamponade
Cardiogenic shock
Cerebrovascular events such as TIA, Stroke
Death
Device embolization / migration
Emergent cardiac surgery
Endocarditis
Exacerbation of heart failure
Hemolysis
Hemorrhage requiring transfusion
Hypertension or hypotension
Infection
Liver failure
Non-structural prosthetic valve dysfunction: paravalvular or/and central regurgitation
Myocardial infarction
Pericardial effusion
Prosthetic valve thrombosis
Pulmonary embolism
Structural prosthetic valve damage (e.g. cusps tear, suture line disruption, stent fracture,
calcification)
Thromboembolism
Vascular injury (dissection, perforation)
Venous congestion
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8. DIRECTIONS FOR USE
8.1 PHYSICIAN TRAINING
The implanting physician should be experienced in port access and catheterization techniques,
the prosthesis implantation procedure, and trained on the use of the Valved Stent Graft
System.
8.2 REQUIRED EQUIPMENT
Standard cardiac catheterization lab equipment is required.
8.3 REQUIRED MATERIAL
Accessories that are required for the preparation of the TRICENTO System before implant
placement can begin:
Min. 3 Liter of NaCl 0.9 % at room temperature (for rinsing of TRICENTO)
3 sterile bowls with a minimum capacity of 1000 ml, minimum Ø = 140 mm (for rinsing of
TRICENTO)
1 Sterile bowl of 200 ml (to prepare 150 ml heparinized solution for rinsing of the delivery
system, dilution: 5000 I.U./L)
20 ml syringe without Luer-Lock (to rinse the Delivery System)
Sterile tweezer (to transfer TRICENTO from product jar)
Loading table with a length of at least 2 m (to load the TRICENTO into the Delivery
System)
TRICENTO Loading System
Devices/accessories required for the preparation of the patient for implantation and for the
implantation itself:
An ultrasound device to examine the patient immediately before the procedure and to
determine the current extent of tricuspid insufficiency and anatomic dimensions
(depending on the anatomy of the patient: TTE or TEE).
All standard procedure devices required for the transfemoral venous access (e.g. catheter
laboratory equipment, fluoroscopy, invasive pressure measurement, antiseptic, surgical
instruments, compresses, swabs, etcetera)
Angiographic catheters (RF Marinr steerable catheter (Medtronic) or ViaCath (Biotronik)
or Pigtail catheter or Q5 Guiding (Boston))
0.035” (0.089 mm) Guide wire, 260 cm (super stiff or extra stiff)
A compatible 26 Fr introducer sheath (only when necessary)
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8.4 INSPECTION PRIOR TO USE
NOTE: Before using the products, check the temperature indicators, the ETO indicator and the
compliance of the patient number by four-eye principle.
Use the Delivery System only if the ETO indicator on the inner sterile bag is green
Do not use if the integrity of the sterile packaging has been compromised
In the event of any non-matching information, do not use the product
Do not use the Bioprosthesis if the product jar is damaged or if the seal is broken or the
outside of the product jar is wet
Do not use the Bioprosthesis if there are any signs of damage
Do not use the Delivery System if there are any signs of damage
Do not use the Bioprosthesis if the warm temperature indicator is black or the cold
temperature indicator’s bulb is purple
8.5 PATIENT SCREENING AND BIOPROSTHESIS SIZING
Anatomical reference points to be considered for the sizing of the Valved Stent Graft
Bioprosthesis:
1. Diameter of vena cava superior at transition to the right atrium (measure circumference)
2. In case of conical SVC, additionally the diameter of the SVC just below (proximal) the
azygous vein ostium
3. Diameter of vena cava inferior at transition to the right atrium (measure circumference)
4. Distance between the ostia of the two caval veins at the transition into the right atrium
5. Distance of the hepatic veins to the ostium of the vena cava inferior at the transition into
the right atrium
6. Position of the ostium of the coronary sinus at the transition into the right atrium
7. Position of the ostium of the azygos vein at the transition into the vena cava superior
References for Bioprosthesis design:
1. Oversizing should be based on the circumference of the vessels rather than an individual
diameter (long or short axis) or the area
2. The range of oversizing of the Bioprosthesis should be between 10% and 30%
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8.6 PATIENT SCREENING AND PROCEDURAL PLANNING
Step Procedure
1 Patients should present a “V-Wave” in the atrial pressure curve prior to
implantation of the device.
2 Patients should show preserved right ventricular systolic function to maximize
the benefit of the implantation of the Valved Stent Graft Bioprosthesis.
3 Measurements of diameters and distances must be performed at different
points of the cardiac cycle and during inspiration and expiration. The largest
diameters (regarding their variability throughout the cardiac/respiratory cycle)
must be taken as a reference for device sizing.
4 The diameters of the caval veins must be between 16 mm and 35 mm to
ensure fit and anchoring of the Bioprosthesis.
5 The risk of hepatic vein occlusion should be judged as higher for patients with
a small distance between the junction of the inferior vena cava and the right
atrium and the orifice of the hepatic veins. Exact pre-procedural planning and
precise imaging are crucial in order to achieve safe device placement.
8.7 TRICENTO DELIVERY SYSTEM HANDLING AND PREPARATION
Step Procedure
1 Remove the Delivery System from the packaging carefully to not compromise
the sterility of the system.
CAUTION: Ensure that the Delivery System is only handled in a sterile
environment.
2 Remove the transport wire from the tip of the Delivery System.
3 Remove the safety stopper before loading the Bioprosthesis inside the Delivery
System. Place the safety stopper within the sterile field.
4 Pre-flush the Delivery System flushing ports with NaCl solution when the
Catheter Shaft is closed.
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8.8 BIOPROSTHESIS RINSING PROCEDURE
Step Procedure
1 Fill the three rinsing bowls with 1000 ml of sterile saline solution each.
2 Remove the Valved Stent Graft Bioprosthesis from the product jar and place it
into the rinsing bowl.
CAUTION: Ensure that the Bioprosthesis is only handled in a sterile
environment
3 Rinse the Bioprosthesis for 3 minutes then repeat the rinsing process in the
second bowl. Gently agitate the Bioprosthesis during this process. The
Bioprosthesis then be rinsed a third time in the third rinsing bowl.
CAUTION: Use a separate bowl with new rinsing solution for each step.
NOTE: Ensure not to rinse the Bioprosthesis in an already used rinsing
solution
4 Leave the Bioprosthesis in the NaCl solution to prevent drying out.
CAUTION: The Bioprosthesis must be kept hydrated until being loaded.
8.9 LOADING PROCEDURE
Step Procedure
1 Ensure that the Bioprosthesis has been rinsed properly.
2 Using the Loading Funnel, compress the tips onto the Loading Connector,
ensuring that the tips of the spring slide into the grooves of the Loading
Connector. The lateral valve element should be oriented in the same direction
as the Tactile Marker on the front of the Delivery System grip.
CAUTION: Make sure that the lowest spring of the IVC segment of the device
is loaded into the Loading Connector oriented in the same direction as the
Tactile Marker on the front of the Delivery System grip, to ensure proper
orientation of the valve.
3 With the switch of the Delivery System in the “N” position, slide the retaining
catheter forward by moving the grip towards the tip. Advance the retaining
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Step Procedure
catheter until the Loading Connector is covered and the lower stent tips are
secured inside the retaining catheter.
4 Gently advancing the Loading Funnel, bring the Bioprosthesis to a loadable
diameter and advance the retaining Catheter Shaft.
CAUTION: If you feel any resistance the loading procedure must be stopped
and the cause of the resistance has to be evaluated.
5 Once the Bioprosthesis is completely loaded inside the retaining Catheter Shaft
and this is advanced all the way to the tip, push down on lever of the “Squeeze-
to-Release” handle and slide the switch to the “P” position to secure the lever.
6 Fix the Safety Stopper on the grip of the Delivery System.
CAUTION: If the Safety Stopper is not fixed to the grip of the Delivery System,
the Bioprosthesis could be released accidentally.
8.10 DELIVERY SYSTEM FLUSHING
Using a syringe filled with sterile NaCl solution and heparin, flush all three flushing ports with
50 ml of saline solution each.
8.11 BIOPROSTHESIS DELIVERY
Step Procedure
1 Before starting the procedure the implantation site shall be measured by
echocardiography and/or under fluoroscopy to confirm the measurements
previously performed during diagnostics.
2 Verify that the Bioprosthesis size is adequate for the implantation.
3 Catheterize the vena cava superior using an angiographic catheter in
combination with a 0.035 inch (0.889 mm) guidewire with a soft tip.
4 Perform an exchanging maneuver, remove the guidewire with the soft tip and
advance a stiff guidewire through the catheter to the superior caval vein.
CAUTION: Ensure that the guidewire position is stable. The wire should be
advanced past the bifurcation and into the innominate or subclavian vein.
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Step Procedure
5 After introduction of a pigtail catheter, perform a right atrial angiography to find
the position of the right atrial appendage, native tricuspid annulus, the
transitions from the atrium to the caval veins and the ostia of the hepatic veins.
The structures will serve as a reference during the positioning of the device.
Find a view that is orthogonal to the native tricuspid valve annulus.
6 Mark the transition zone between the IVC and the right atrium by placing a
pigtail or angiographic catheter close to the bottom (caudal) of the right atrium.
CAUTION: Ensure that the position of the catheter is in the correct position.
7 Introduce the Delivery System, flushed, with the Bioprosthesis loaded on it and
with the handle switch in the position P, over the guidewire under fluoroscopic
guidance, while maintaining guidewire position.
NOTE: Before introducing the Delivery System into the patient, visually check
for correct loading of the Bioprosthesis and the complete closure of the
retaining catheter against the tip.
8 Introduce the Delivery System until the Bioprosthesis is at the implantation site.
CAUTION: If you feel any resistance the procedure must be stopped and the
cause of the resistance has to be evaluated.
8.12 BIOPROSTHESIS DEPLOYMENT
Step Procedure
1 Perform gentle push-pull movements of the Delivery System to precisely
position and align the Bioprosthesis to the desired implantation position.
Laterally turn the Bioprosthesis until the gold markers indicating the opening of
the lateral valve element are correctly positioned, facing the right atrial
appendage and allowing the valve element to open entirely in the right atrium
without touching the atrial wall.
2 Step 1: Opening
With the switch in position D repeatedly squeeze the lever to retract the
retaining Catheter Shaft and release the Bioprosthesis.
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Step Procedure
The Catheter Shaft will open and the Bioprosthesis will expand starting in its
SVC portion.
CAUTION: Stably hold the Delivery System at the Integrated Sheath in order
to avoid a change in the position.
3 When the springs of the lateral valve element are released from the catheter,
verify that the opening is in the correct direction. Ensure that the Bicuspid Valve
opens completely and is not impeded by contact with adjacent anatomical
structures.
4 Squeeze the lever until reaching the Safety Stopper, at which point the
retaining Catheter Shaft is no longer retracted.
5 After the correct alignment and the confirmation of the safe orientation and
position of the Bioprosthesis in relation to the adjacent anatomical structures,
hold the catheter securely at the Integrated Sheath to keep the position of the
Bioprosthesis and remove the Safety Stopper. Then continue to squeeze down
the lever of the handle to further retract the retaining Catheter Shaft. The
Bioprosthesis will be released and the IVC end opens.
CAUTION: Keep the Delivery System very stable not to dislocate the
Bioprosthesis.
6 Double check if the Bioprosthesis is free from the catheter before starting the
withdrawal procedure.
8.13 WITHDRAWAL OF THE DELIVERY SYSTEM
Step Procedure
1 Slowly withdraw the Delivery System and observe under fluoroscopy if the
catheter tip is not trapped or dragging the Bioprosthesis.
3 After the tip crossed the Bioprosthesis gently retract the Delivery System into
the IVC and close the catheter to be withdrawn. Set the handle switch to the
neutral position N and hold the front cap of the Delivery System with one hand.
Slowly move the handle forward with the other hand. Advance the handle until
the retaining catheter reaches the tip.
CAUTION: Do not force the catheter against the tip to avoid overlapping.
4 The closure enables to withdraw the Delivery System without excessive
bleeding.
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8.14 VERIFICATION OF PROSTHETIC VALVE POSITION AND MEASUREMENTS
Step Procedure
1 Cross the valve element of the Bioprosthesis with a pigtail catheter and perform
an angiogram to verify sealing and positioning of the device.
NOTE: This has to be performed under fluoroscopy control and paying
attention not to move the Bioprosthesis.
2 Place a pigtail catheter to a position inferior to the IVC portion of the
Bioprosthesis within the IVC and perform an injection of contrast to confirm the
position of the Bioprosthesis and patency of the hepatic veins.
3 Assess the sealing of the valve element and of the Bioprosthesis in the inferior
and superior vena cava via echocardiography. Using Doppler, measure the
gradient across the bicuspid valve element.
4 Measure and record the central venous, right atrial and right ventricular
pressure.
5 Remove all catheters and sheaths.
6 Perform the closure of the arterial access according to current techniques and
devices.
9. HOW SUPPLIED
9.1 AVAILABLE SIZES
This product is a custom made device manufactured for a specific patient and may only be
used for the treatment of this specific patient.
9.2 PACKAGING
The Bioprosthesis is sterilized with and stored in glutaraldehyde solution. The Bioprosthesis is
supplied sterile in a sealed product jar with a screw cap. The outside of the product jar is non-
sterile and must not be placed in the sterile field. A warm and a cold temperature indicator are
placed inside the carton box. In total the packaging consists of a transport box (carton and
polystyrene), the product box and the product jar.
CAUTION: Do not use the Bioprosthesis if the warm temperature indicator is black or the cold
temperature indicator’s bulb is purple.
NOTE: After implantation of the Bioprosthesis, the glutaraldehyde solution should be disposed
according to hospital procedure.
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The Delivery System is sterilized with ethylene oxide gas (ETO). The Delivery System is sterile
if the sterile bags are undamaged and unopened and the ETO indicator is green. The outer
surface of the outer bag is non-sterile and must not be placed in the sterile field. The packaging
of the Delivery System consists of a transport box (carton), the product box and two sterile
pouches.
CAUTION: Use the Delivery System only if the ETO indicator on the inner sterile bag is green.
NOTE: The used Delivery System may be disposed in the same manner that the hospital
waste and bio-hazardous materials are handled. There are no special or unusual risks related
to the disposal of the Delivery System.
The Loading System is sterilized with ethylene oxide gas (ETO). The Loading System is sterile
if the sterile bag is undamaged and unopened and the ETO indicator is green. The outer
surface of the outer bag is non-sterile and must not be placed in the sterile field.
CAUTION: Use the Loading System only if the ETO indicator on the inner sterile bag is green.
NOTE: The used Loading System may be disposed in the same manner that the hospital waste
and bio-hazardous materials are handled. There are no special or unusual risks related to the
disposal of the Delivery System.
9.3 STORAGE
The Bioprosthesis must be stored between 10°C and 38°C. Avoid locations where extreme
temperature fluctuation may occur.
CAUTION: Do not freeze. Always store the Bioprosthesis in a cool, dry place. Any
Bioprosthesis that has been frozen must not be used for human implantation.
The Delivery System should be stored in a cool, dry place between 10°C and 38°C.
The Loading System should be stored in a cool, dry place between 10°C and 38°C.
10. MRI SAFETY INFORMATION
Nonclinical testing indicates that the Valved Stent Graft Bioprosthesis is MR conditional. It can
be scanned under the following conditions:
Static magnetic field of ≤ 1.5 Tesla
Normal mode of MR system
MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the Bioprosthesis.
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11. INFORMATION ON THE MATERIALS AND SUBSTANCES TO
WHICH THE PATIENT CAN BE EXPOSED
Components and materials of the Bioprosthesis:
Components Materials
Pericardium (leaflets and cover of the stent graft)
Porcine pericardium (cross linked with glutaraldehyde phosphate buffered solution)*
Suture material Polytetrafluoroethylene (PTFE)
Support stent structure Nitinol
Radiopaque markers Gold
*As the Bioprosthesis contains animal tissue which is rendered non-viable, it is subject to
Commission Regulation (EU) No 722/2012.
Components and materials of the Delivery System:
Components Materials
Handle Polycarbonate (PC) Nitinol Stainless Steel
Catheter Stainless Steel Silicone Thermoplastic polyurethane (TPU) Polyethylen (HDPE/ LDPE)
Others Polyetheretherketon PEEK Glue Polycarbonate (PC) Ethyl-2-cyanoacrylate
Components and materials of the Loading System:
Components Materials
Funnel Polycarbonate (PC)
Quantitative information about the materials can vary from patient to patient. Never the less
the maximum acceptable amount of each material is determined by New Valve Technology
and was tested with respect to biocompatibility.
Implant pyrogenicity and bioburden are evaluated for each bioprosthesis.
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12. PATIENT INFORMATION
An implant card and patient leaflet for the patient is included in each product package of the
implantable device. The implant card contains blank fields to enter the patient name, date of
implantation and healthcare institution filled by handwritten text. Information to identify the
implanted device including device name, device model (device type), patient number as well
as manufacturer address and website is provided by suitable implant card device stickers.
Stickers are included within the device package of the implantable device. The implant card
contains a dedicated field to place the implant card device sticker. The patient leaflet includes
information regarding warnings, precautions or measures, expected lifetime of the device and
necessary follow-up information. It also contains information for a healthcare professional with
regard to reciprocal interference with reasonably foreseeable external influences, medical
examinations or environmental conditions. Also the overall qualitative and quantitative
information on the materials and substances to which patients can be exposed is included in
the patient leaflet.
Note: The healthcare institution must ensure that the patient receives an implant card
completely filled with all the predefined information as well as the information given by the
patient leaflet.
Note: Only a complete filled implant card allows the patient to have access to device related
information.
13. TRAINING
NVT provides detailed operator training. For training material and in-service support contact a
NVT representative.
CAUTION: Implantation of the Valved Stent Graft Bioprosthesis may only be performed by
physicians who have received an appropriate training.
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14. REPORTING TO MANUFACTURER AND COMPETENT
AUTHORITY
Any health care professional (e.g. customer or user of the device) and/or patient treated with
the TRICENTO device who has identified any serious incident that has occurred in relation to
the provided device should inform the manufacturer and the local competent authority
immediately. The manufacturer has to be notified by telephone, FAX, or in written
correspondence. When reporting a serious incident provide device name and model, lot
number or serial number and the nature of incident.
15. PERFORMANCE CHARACTERISTICS OF THE DEVICE AND THE
SPECIFICATION OF CLINICAL BENEFITS TO BE EXPECTED
As the TRICENTO System is a custom made device, there are no specific performance
characteristics of the device available.
However, the prosthesis was extensively tested in in vitro and animal experiments during its
development.
All tests showed that the TRICENTO device meets all requirements demanded by all relevant
norms and rules.
According to accelerated wear tests (in vitro tests) the prosthesis showed a reliable and error-
free functioning (prevention of blood backflow) for more than 200 Mio heart cycles.
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Rev. 00081701_072020_04
NVT GmbH
Lotzenäcker 17
72379 Hechingen
GERMANY
Phone: +49 (0) 7471 98979-0
Fax: +49 (0) 7471 98979-222
www.nvt-med.com