Ovation TriVascular User manual

810-0005-01-05 Rev B
Instructions for Use
(810-0005-01-05)
EN
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Table of Contents
1. Device Description............................................................ 3
1.1. Delivery System........................................................3
1.2. Fill Polymer...............................................................4
1.3. Ancillary Components ...............................................5
2. Indications for Use.......................................................... 5
3. Contraindications............................................................ 5
4. Warnings and Precautions ............................................. 6
4.1. General.....................................................................6
4.2. Patient and Device Selection .................................... 6
4.3. Implant procedure.....................................................6
5. Adverse Events ............................................................... 7
5.1. Potential Adverse Events ..........................................7
5.2. Incident Reporting.....................................................8
6. Patient Selection and Treatment .................................... 9
6.1. Individualization of Treatment....................................9
6.2. Specific Patient Populations......................................9
7. Patient Counseling Information...................................... 9
8. How Supplied ................................................................ 10
8.1. Ovation Stent Graft & Delivery Systems .................. 11
8.2. Fill Polymer Kit & Autoinjector ................................. 11
9. Clinician Use Information ............................................. 12
9.1. Physician Training .................................................. 12
9.2. Inspection Prior to Use............................................12
9.3. Materials Required.................................................. 12
9.4. MRI Information ...................................................... 14
10. Directions for Use ......................................................... 15
10.1. Patient Preparation ................................................. 15
10.2. Implant Procedure .................................................. 15
10.3. Deployment Instructions.......................................... 15
11. Follow-up Imaging Recommendations......................... 21
12. Symbols......................................................................... 23

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1. Device Description
The TriVascular Ovation™ Abdominal Stent Graft System is an endovascular device
delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The
stent graft is designed to reline the diseased vasculature, providing an alternate
endovascular blood conduit for isolating the aneurysm from the high pressure flow of
blood, thereby reducing or eliminating the risk of rupture. The stent graft is a modular
configuration comprised of an aortic body section, two iliac limbs, and iliac
extensions as required (Figure 1).
The TriVascular Ovation Abdominal Stent Graft System includes:
•An Aortic Body Stent Graft and delivery catheter
•Two Iliac Limb Stent Grafts and delivery catheter
•Iliac Extension Stent Grafts and delivery catheter, as required
•A Fill Polymer Kit
•An Autoinjector
The aortic section is comprised of a proximal stent for suprarenal fixation and a low-
permeability PTFE graft. The stent is designed with integral anchors to enable
fixation to the aortic wall. For delivery, the stent is in a compressed state within the
catheter. When released from the compressed state, the stent expands to engage
the vessel wall. The nitinol stent is radiopaque and the implant contains radiopaque
markers adjacent to the proximal graft edge. These radiopaque markers serve as
positioning aids during placement of the device and allow the implant to be located
so that it can be positioned to not obstruct the renal arteries. To seal the proximal
end of the graft and to provide support into which the iliac limbs are deployed, the
graft body contains a network of inflatable rings that are filled with a liquid polymer
that solidifies during the deployment procedure. The graft has a fill port that connects
the fill network of the graft to the delivery catheter.
The iliac limbs and extensions are comprised of a nitinol stent encapsulated in PTFE.
The limbs are deployed into the limb section of the aortic body. Radiopaque markers
allow the physician to visualize the appropriate iliac limb - aortic body overlap or iliac
extension – iliac limb overlap during a catheter-based deployment. Stent radial force
provides both fixation and sealing of the interface between the aortic body and each
iliac limb, between the iliac limb and iliac extension, and between the iliac
limb/extension and its landing zone in the iliac artery.
Figure 1. Schematic of Deployed TriVascular Ovation Abdominal Stent Graft
1.1. Delivery System
To facilitate device introduction into the access vessel, the aortic body, the iliac limbs,
and the iliac extensions are preloaded into low-profile delivery catheters (14F–15F
OD, 13F–15F OD, and 13F – 14F OD respectively, Figure 2 and Figure 3). The
aortic body is deployed via the aortic body delivery catheter. The aortic body delivery
catheter has a lumen that allows for the use of a guidewire to help deliver the stent
graft to the deployment site.
During stent graft deployment, the device is first positioned and the sheath is
retracted. The proximal stent is then deployed using stent release knobs on the
handle. The fill polymer is then delivered through the fill connector port using the
autoinjector (supplied).

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The contralateral and ipsilateral iliac limbs are each deployed via iliac limb delivery
catheters. After deployment of the aortic body, a guidewire is placed from the
contralateral access site into the contralateral distal leg of the aortic body. The
contralateral iliac limb is then advanced into position and deployed into the aortic
body by retracting the catheter sheath with the catheter in the appropriate position.
After the fill polymer cures within the sealing rings, the aortic body delivery catheter
is disengaged from the fill port of the graft and withdrawn from the vasculature. The
ipsilateral iliac limb delivery catheter is then advanced over the ipsilateral guidewire
and deployed using the method described above for the contralateral limb.
If an iliac extension is required, the delivery system is advanced over the guidewire
and deployed using the method described above for contralateral and ipsilateral iliac
limbs.
Figure 2. Schematic of TriVascular Ovation Abdominal Stent Graft System aortic
body delivery catheter
Figure 3. Schematic of TriVascular Ovation Abdominal Stent Graft System iliac
limb/ iliac extension delivery catheter
The TriVascular Ovation Abdominal Stent Graft System is designed to
accommodate various aortic anatomies, including a range of proximal and distal
aortic neck diameters and aneurysm lengths. Refer to Table 1 for patient sizing
information and Tables 2-4 for product sizes and configurations.
1.2. Fill Polymer
The fill polymer is comprised of three components and is supplied in kit form as
shown in Figure 4. Upon mixing and injection into the graft, the components form a
robust radiopaque polymer network that is durable in vivo. Once inside the PTFE
channels in the wall of the aortic body graft, the fill polymer forms conformable
“gasket-like” sealing rings. The fill polymer radiopacity dissipates over time and may
not be visible on fluoroscopy beyond 1-2 months post-implant.
Just prior to use, the two valves on the kit are opened and the fill polymer is mixed
by alternately depressing the two syringe plungers for a minimum of 20 full strokes.
Thereafter, the fill syringe is disconnected from the connection tube, slipped out of
the syringe support and connected to the fill polymer injection port on the catheter
handle. The syringe plunger is then inserted into the autoinjector (Figure 5), and the
syringe given a quarter-turn to lock it in place. The autoinjector applies controlled
pressure to inject the fill polymer into the graft without requiring continuous attention
from the operator.

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Figure 4. TriVascular Fill Polymer Kit
1.3. Ancillary Components
Figure 5. TriVascular Autoinjector
2. Indications for Use
The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects
diagnosed with an aneurysm in the abdominal aorta having vascular morphology
suitable for endovascular repair, including:
•Adequate iliac/femoral access compatible with vascular access techniques,
devices, and/or accessories,
•Non-aneurysmal proximal aortic neck:
-with a length of at least 7 mm proximal to the aneurysm,
-with an inner wall diameter of no less than 16 mm and no greater than 30
mm, and
-with an aortic angle of ≤60 degrees if proximal neck is ≥10 mm and ≤45
degrees if proximal neck is < 10 mm,
•Non-aneurysmal distal iliac landing zone:
-with a length of at least 10 mm,
-with an inner wall diameter of no less than 8 mm and no greater than 20
mm.
3. Contraindications
•Patients who have a condition that threatens to infect the graft.
•Patients with sensitivities or allergies to the device materials.