Ovation TriVascular User manual

810-0005-01-05 Rev B
Instructions for Use
(810-0005-01-05)
EN
0 0 5 00 0 5 0

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.

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4. Warnings and Precautions
4.1. General
•Accurate fluoroscopic imaging is required during any endovascular
procedure and for proper device deployment. Implantation of this device
should occur in an operating room, endovascular suite, catheterization
laboratory, or similar sterile environment, with appropriately trained
personnel, and suitable equipment and imaging capabilities.
•Do not use this device if the patient is unable to be evaluated using the
necessary preoperative and postoperative imaging.
•Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to
the patient.
•Always have a qualified surgery team available during implantation or re-
intervention procedures in the event that conversion to open surgical repair
is necessary.
•The TriVascular Ovation Abdominal Stent Graft System should only be used
by physicians and teams experienced in endovascular techniques, and who
have been trained in its use. This experience should include:
-Vascular access techniques
-Guidewire and catheter techniques
-Fluoroscopic and angiographic image interpretation
-Embolization
-Angioplasty
-Endovascular stent placement
-Appropriate use of contrast agents
-Techniques to minimize radiation exposure
-Expertise in patient follow-up modalities
•The long-term performance of this implant has not been established. All
patients treated with this device must undergo periodic imaging to evaluate
the stent graft, aneurysm size, aneurysm pulsatility, device migration, leaks,
device integrity and occlusion of vessels in the treatment area. Significant
aneurysm enlargement, evidence of perigraft flow, the appearance of a new
endoleak, change in aneurysm pulsatility, device migration and/or reduced
blood flow through the graft should prompt further investigation into the need
for further patient treatment.
•All patients should be carefully counseled on the need for long-term follow
up. The device is not recommended in patients unable or unwilling to comply
with the information in Follow-up Imaging Recommendations.
4.2. Patient and Device Selection
•Access vessel diameter, vessel morphology and delivery system diameter
should be compatible with vascular access techniques. Vessels that are
significantly calcified, occlusive, tortuous or thrombus-lined may preclude
placement of the device.
•Irregular calcification and/or plaque may compromise the fixation and
sealing of the implantation sites.
•This device is not recommended in patients who: have or are suspected of
having an active systemic infection; cannot tolerate contrast agents
necessary for intra-operative and post-operative follow up imaging; and/or
have sensitivities or allergies to the stent graft system materials.
4.3. Implant procedure
•Carefully inspect the device packaging and device for damage or defects
prior to use. If signs of damage or defects exist or if premature breach of the
sterile barrier is observed, do not use the device.

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•Do not resterilize any components of the Ovation Abdominal Stent Graft
System.
•Systemic anticoagulation should be used during the implantation procedure
based on hospital and physician preferred protocol. If heparin is
contraindicated, an alternative anticoagulant should be considered.
•Do not bend or kink the Ovation Abdominal Stent Graft System because it
may damage the device and/or its components.
•Always use fluoroscopic guidance to advance the delivery system and to
monitor the implant procedure and the device deployment.
•Inaccurate placement or inadequate seal may result in increased risk of
leakage into the aneurysm.
•Do not continue advancing any portion of the delivery system if resistance is
felt during advancement of procedure accessories or of stent graft system.
Exercise particular care in areas of stenosis, intravascular thrombosis, or in
calcified or tortuous vessels.
•Unless medically indicated, do not deploy the stent graft components in a
location that will occlude arteries necessary to supply blood flow to organs or
extremities.
•Patients who experience hypersensitivity reactions during the procedure
should be managed in accordance with standard recommendations for
treatment of patients with radiocontrast agent allergies (e.g., antihistamines,
corticosteroids, adrenaline).
5. Adverse Events
5.1. Potential Adverse Events
Adverse events that may occur include but are not limited to:
•Acute and chronic renal failure, renal microembolism, renal insufficiency,
renal artery occlusion, contrast toxicity;
•Allergic reaction to x–ray dye, anti-platelet therapy, device materials;
•Anesthetic complications and subsequent attendant problems (aspiration);
•Aneurysm enlargement or rupture;
•Blood or bleeding events such as anemia, gastrointestinal bleeding,
retroperitoneal bleeding;
•Bowel events such as bowel ischemia, bowel necrosis, colon ischemia,
paralytic or adynamic ileuses, obstruction, fistulas;
•Cardiac events and subsequent attendant problems such as congestive
heart failure, volume overload, arrhythmias, myocardial infarction, chest
discomfort or angina, elevations in creatinine phosphokinase (CPK),
hypotension, hypertension;
•Cerebral events (local or systemic) and subsequent attendant problems
such as change in mental status, cerebrovascular accident (hemorrhagic or
embolic), reversible ischemic neurologic deficit, nerve injury, transient
ischemic attacks, paraplegia, paraparesis, paralysis;
•Death;
•Device events such as deployment or device malfunction, loss of stent graft
system component integrity, endograft occlusion, migration, or dislodgement,
endoleak;
•Embolic and thrombotic events such as deep vein thrombosis,
thromboembolism, microembolism, thrombophlebitis, phlebothrombosis, air
embolism;
•General discomfort related to the procedure;
•Generalized inflammatory response that may be associated with elevated
levels of systemic mediators of inflammation, elevated temperature;

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•Genitourinary complications and subsequent attendant problems such as
ischemia, erosion, fistula, incontinence, hematuria, infection;
•Hepatic failure;
•Insertion and other vascular access site complications such as infection,
bleeding, pain, delayed healing, abscess formation, hematoma, dehiscence,
seroma, nerve injury/damage, neuropathy, neuralgia, vasovagal response,
pseudoaneurysm, anastomotic false aneurysm, arteriovenous fistula;
•Impotence/ sexual dysfunction;
•Lymphatic complications and subsequent attendant problems such as
lymphocele, lymph fistula;
•Multi-system organ failure;
•Neoplasm;
•Operative and post–operative bleeding and hemorrhage, coagulopathy;
•Paralysis (temporary or permanent) such as paraplegia, monoplegia, paresis,
spinal cord ischemia, hemiplegia, bowel or bladder incontinence;
•Pericarditis;
•Possible infection–urinary tract, systemic or localized, endograft;
•Pneumothorax;
•Pulmonary/respiratory events and subsequent attendant problems such as
pulmonary insufficiency, pneumonia, respiratory depression or failure,
pulmonary edema, pulmonary embolism, atelectasis, pleural effusion;
•Radiation injury, late malignancy;
•Sepsis;
•Seroma;
•Shock;
•Spinal neurological deficit;
•Surgical conversion to open repair; and/or
•Vascular spasm or vascular injury/trauma including damage to blood vessels
and surrounding tissues, atherosclerotic ulcer, vessel dissection, perforation,
plaque dissection, stenosis, pseudoaneurysm, collateral vessel occlusion,
embolization, ischemia, tissue loss, limb loss, gangrenous disease,
worsened or new onset claudication, edema, fistula, bleeding, rupture, death.
5.2. Incident Reporting
All incidents should be reported to TriVascular immediately. To report an event,
contact your local representative and/or the Authorized Representative at the contact
number provided at the end of this document.

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6. Patient Selection and Treatment
6.1. Individualization of Treatment
The TriVascular Ovation Abdominal Stent Graft System must be selected in a size
appropriate to the patient’s anatomy. The sizing options for the device are detailed in
Table 1 Patient Sizing Information.
Table 1. Patient Sizing Information
Aortic Body
Iliac Limb / Extension
Stent Graft
Diameter, mm
Aortic I
D,
mm*
Stent Graft
Diameter, mm
Iliac ID,
mm
34 27-30 22 18-20
29 24-26 18 16-17
26 21-23 16 14-15
23 18-20 14 12-13
20 16-17 12 10-11
10 8-9
* At the intended proximal sealing ring location. Ensure adequate oversizing of the
proximal stent at its anchoring location.
The recommended overall length of the deployed, implanted system should extend
from the lowest renal artery to just above the internal iliac bifurcation. If pre-operative
case planning measurements are not certain, ensure that all potential stent graft
lengths and diameters are available to complete the procedure.
Considerations for patient selection include but are not limited to:
•Patient’s age and life expectancy
•Co-morbidities (e.g., cardiac, pulmonary or renal insufficiency prior to
surgery, morbid obesity)
•Patient morphologic suitability for endovascular repair
•Patient’s suitability for open surgical repair
During the case planning process, TriVascular may consult with physicians in their
efforts to determine appropriate stent graft sizing.
6.2. Specific Patient Populations
The Ovation Abdominal Stent Graft System has not been evaluated in patients who:
•Are pregnant or nursing;
•Have traumatic aortic injury;
•Have suprarenal or thoraco-abdominal aneurysms;
•Have acutely ruptured aneurysms or aneurysms pending rupture;
•Have hypercoagulability;
•Have ilio-femoral, thoracic or inflammatory aneurysms;
•Have juxtrarenal AAA;
•Have pararenal AAA;
•Have mesenteric artery occlusive disease;
•Have connective tissue disorder.
7. Patient Counseling Information
Prior to treatment, the physician should review with the patient the risks and benefits
of this endovascular procedure, including:
•Risks, benefits and differences of open surgical repair;
•Risks, benefits and differences of endovascular repair;

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•The long-term safety and effectiveness of endovascular repair has not been
established;
•The importance of life-long, regular follow up to assess patient’s health
status and the stent graft performance;
•Subsequent endovascular or open surgical repair of the aneurysm may be
required;
•Signs to seek prompt medical attention (including limb occlusion, aneurysm
enlargement, or rupture).
8. How Supplied
The Ovation Abdominal Stent Graft System is comprised of the aortic body stent
graft/ delivery system, the iliac limbs and extensions stent graft/ delivery system, the
fill polymer kit, and the autoinjector.
The stent grafts are available in the following sizes and configurations.
Table 2. Ovation Aortic Body Stent Graft sizes
Stent Graft
Proximal
Diameter
Catheter
Working
Length
Delivery
System Outer
Profile
Covered Stent
Graft Length
20 mm 57 cm 14 F 80 mm
23 mm
26 mm
29 mm
34 mm 15 F
Table 3. Ovation Iliac Limb sizes
Stent Graft
Proximal
Diameter
Stent Graft
Distal
Diameter
Catheter
Working
Length
Delivery
System
Outer
Profile
Covered
Stent Graft
Length
14 mm 10 mm 53 cm 13 F 80 mm
10 mm 100 mm
10 mm 120 mm
10 mm 140 mm
12 mm 80 mm
12 mm 100 mm
12 mm 120 mm
12 mm 140 mm
14 mm 80 mm
14 mm 100 mm
14 mm 120 mm
14 mm 140 mm
16 mm 14 F 80 mm
16 mm 100 mm
16 mm 120 mm
16 mm 140 mm

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Stent Graft
Proximal
Diameter
Stent Graft
Distal
Diameter
Catheter
Working
Length
Delivery
System
Outer
Profile
Covered
Stent Graft
Length
18 mm 80 mm
18 mm 100 mm
18 mm 120 mm
18 mm 140 mm
22 mm 15 F 80 mm
22 mm 100 mm
22 mm 120 mm
22 mm 140 mm
Table 4. Ovation Iliac Extension sizes
Stent Graft
Proximal and
Distal Diameter
Catheter
Working
Length
Delivery
System Outer
Profile
Covered Stent
Graft Length
10 mm 53 cm 13 F 45 mm
12 mm
14 mm
16 mm
18 mm 14 F
22 mm
8.1. Ovation Stent Graft & Delivery Systems
Contents are supplied STERILE and non-pyrogenic using an ethylene oxide (EO)
process.
•Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damaged or if the sterilization
barrier has been damaged or broken.
•Do not use after the expiration date printed on the label.
•Store in a cool, dry place.
•For single patient use only. Do not reuse, reprocess or re-sterilize. Reuse,
reprocessing or re-sterilization may compromise the structural integrity of the
device and/or lead to device failure that may result in patient injury, illness or
death. Reuse, reprocessing or re-sterilization may also create a risk of
contamination of the device and/or cause patient infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness or death of
the patient.
•After use, dispose of the product and packaging in accordance with hospital,
administrative and/or local government policy.
8.2. Fill Polymer Kit & Autoinjector
Contents are supplied STERILE using an E-beam sterilization process. The Fill
Polymer Kit is non-pyrogenic.
•Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damaged or if the sterilization
barrier has been damaged or broken.
•Do not use after the expiration date printed on the label.

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•Store in a cool, dry place.
•For single patient use only. Do not reuse, reprocess or re-sterilize. Reuse,
reprocessing or re-sterilization may compromise the structural integrity of the
device and/or lead to device failure that may result in patient injury, illness or
death. Reuse, reprocessing or re-sterilization may also create a risk of
contamination of the device and/or cause patient infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness or death of
the patient.
•After use, dispose of the product and packaging in accordance with hospital,
administrative and/or local government policy.
9. Clinician Use Information
9.1. Physician Training
CAUTION: Always have a vascular surgery team available during
implantation or re-intervention procedures in the event that conversion to
open surgical repair is necessary.
CAUTION: The Ovation Abdominal Stent Graft System should only be used
by physicians and teams trained in vascular interventional techniques and
in the use of this device.
The recommended skill/ knowledge requirements for physicians using the Ovation
Abdominal Stent Graft System are outlined below.
Patient Selection:
•Knowledge of the natural history of abdominal aortic aneurysm (AAA) and
co-morbidities associated with AAA repair.
•Knowledge of radiographic image interpretation, device selection and sizing.
A multi-disciplinary team that has combined procedural experience with:
•Femoral cutdown, arterial bypass, arteriotomy, and repair
•Percutaneous access and closure techniques
•Non-selective and selective guidewire and catheter techniques
•Fluoroscopic and angiographic image interpretation
•Embolization
•Angioplasty
•Endovascular stent placement
•Snare techniques
•Appropriate use of radiographic contrast material
•Techniques to minimize radiation exposure
•Expertise in necessary patient follow-up modalities
9.2. Inspection Prior to Use
Inspect the device and packaging to verify that no damage has occurred as a result
of shipping. Do not use this device if damage has occurred or if the sterilization
barrier has been damaged or broken. If damage has occurred, do not use the
product and contact your TriVascular representative for return information.
9.3. Materials Required

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Table 5. Equipment and Ancillary Items
Required Equipment Ancillary Equipment
TriVascular Ovation Abdominal
Stent Graft Aortic Body
preloaded in Delivery System
TriVascular Ovation Abdominal
Stent Graft Iliac Limbs (2)
preloaded in Delivery Systems
TriVascular Ovation Abdominal
Stent Graft Iliac Extensions
preloaded in Delivery Systems
TriVascular Fill Polymer Kit Timer or clock
TriVascular Autoinjector
Imaging Equipment with
capability to record and recall all
imaging
•Imaging table, or operating room
table designed for use with C-arm
•Fluoroscopy capability
•Digital Subtraction Angiography
(DSA) capability
•Appropriate personnel protection
equipment for fluoroscopy
Video recorder
Power injector with associated
supplies
Angiography and exchange
catheters
Assortment of adequate sizes
(0.035" compatible) and assorted
lengths
Guidewires: Assorted sizes of
physician’s preference, 0.035"
compatible, 150 cm compatible
Contrast media
Heparinized saline and flushing
syringes
Radiopaque ruler with centimeter
increments, or equivalent
Vascular instruments and
supplies
Endovascular supplies
•3-way stopcocks
•Tuohy-Borst adaptors
Optional:
•Introducer sheaths < 35 cm
length
•Range of appropriately sized
(balloon diameter and length and
shaft length) angioplasty
balloons:
-12 mm diameter non-compliant

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Required Equipment Ancillary Equipment
balloon(s) for possible
ballooning of iliac limb to aortic
body junction;
-Non-compliant balloons for
treatment of and equivalent
size to the distal iliac diameter;
-Compliant and non-compliant
balloons for treatment of and
equivalent size to the aortic
diameter.
•Range of sizes of commercial
stents
•Embolization devices such as
coils
9.4. MRI Information
MR Conditional
MR Conditional
The Ovation Abdominal Stent Graft System was determined to be MR Conditional.
Non-clinical testing demonstrated that the Ovation Abdominal Stent Graft System is
MR Conditional. A patient with this device can be scanned safely, immediately after
placement under the following conditions:
Static Magnetic Field
- Static magnetic field of 3-Tesla or less
- Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the Ovation Abdominal Stent Graft System produced the
following temperature rises during MRI performed for 15-min of scanning (i.e., per
pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical Solutions,
Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded,
horizontal field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software
14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:
1.5-Tesla 3-Tesla
MR system reported, whole body averaged SAR
2.9-W/kg 2.9-W/kg
Calorimetry measured values, whole body averaged
SAR
2.1-W/kg 2.7-W/kg
Highest temperature change +1.9 ˚C +2.3 ˚C
These temperature changes will not pose a hazard to a human subject under the
conditions indicated above.
Artifact Information
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 Ovation Abdominal Stent Graft System.
Therefore, optimization of MR imaging parameters to compensate for the presence
of this device may be necessary.

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Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size 8,875 353 12,026 628
Plane Orientation Parallel Perpendicular Parallel Perpendicular
The artifacts extend approximately 4- to 6-mm from the metallic portion of the
device, both inside and outside the device lumen.
10. Directions for Use
10.1. Patient Preparation
•In general, utilize similar patient pre-operative steps as for standard AAA
open repair: fasting, bowel preparation, and prophylactic antibiotic regimens.
Prepare and drape the patient for an open surgical AAA procedure, in the
event that conversion to open repair is required.
•The patient anesthesia protocol utilized during the endovascular procedure
is left to the discretion of the implanting physician and anesthesiologist.
General anesthesia, regional anesthesia, or local anesthesia combined with
conscious sedation are all successfully utilized during endovascular
procedures.
•Appropriate procedural imaging is required to successfully position the
TriVascular Ovation Abdominal Stent Graft System in the vasculature and to
assure appropriate arterial wall apposition. Always use fluoroscopy for
guidance, delivery, and observation of the TriVascular Ovation Abdominal
Stent Graft System within the vasculature.
10.2. Implant Procedure
•Do not kink the delivery catheters. Doing so may cause damage to the
delivery catheters and the TriVascular Ovation Abdominal Stent Graft
System.
•Systemic anticoagulation should be used during the implantation procedure
based on hospital and physician preferred protocols. If heparin is
contraindicated, an alternative anticoagulant should be considered.
•Minimize handling of the stent graft constrained on the delivery catheter
during preparation and insertion to decrease the risk of contamination and
infection.
•Do not continue advancement of the guidewire or delivery catheter if
resistance is felt, as vessel or delivery catheter damage may occur. Stop
and assess the cause of the resistance.
•Inadvertent partial deployment or migration of the stent graft may require
surgical removal or repair.
10.3. Deployment Instructions
Vascular Access
1 Establish bilateral access using standard interventional technique.
2 Place an angiographic catheter suprarenal from contralateral side and
perform angiographic assessment of patient’s vasculature.
3 Identify reference positions for renal arteries.
4 Insert a 0.035" guidewire on ipsilateral side and position appropriately.
Delivery System(s) Preparation
1 Inspect all packaging for damage or loss of sterile barrier. If damage is
observed, replace with another device.
2 Remove delivery system from its sterile package.

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3 Using sterile technique, place delivery system onto sterile field.
4 Inspect delivery system for damage; if present, replace device.
5 For the aortic body only, carefully retract delivery system outer sheath
approximately 1 cm to facilitate retraction within the vasculature.
Advance catheter sheath to its original position. If sheath retraction is
difficult, replace device.
6 Flush delivery sheath with heparinized saline using the sheath flush
port.
7 Flush guidewire lumen (blue cap) with heparinized saline using
guidewire flush port on handle while placing a finger over the open end
of the guidewire port. Close blue cap.
Aortic Body Insertion and Deployment
1 Remove introducer sheath from ipsilateral access site (if applicable).
2 Load aortic body delivery system over guidewire.
3 Activate hydrophilic coating on delivery sheath exterior by gently wiping
surface with heparinized saline.
4 Using continuous fluoroscopic guidance, insert delivery system into
vasculature and advance it until the implant marker coils are about 1
cm proximal to the intended landing site.
5 Orient aortic body laterally within aneurysm sac until nosecone
radiopaque marker or fill tube radiopaque marker is toward patient’s
ipsilateral side.
CAUTION: Rotate entire delivery system as a unit. (Do not
independently rotate catheter sheath or handle.)
6 Under fluoroscopic guidance, retract delivery system outer sheath until
the sheath retraction knob meets handle.
7 Verify implant marker coil positioning is just proximal to the landing site.
If necessary, carefully reposition delivery system.
8 Deploy first segment of proximal stent: turn first stent release knob ¼
turn counterclockwise and then steadily pull knob and attached wire
from handle.
9 Orient C-Arm to align implant marker coils to achieve orthogonality of
view.
10 Precisely position implant marker coils at proximal landing site. Using
contrast injections, as needed, confirm position of the implant relative to
renal arteries.
11 Retract angiographic catheter away from proximal stent, if necessary.
12 Deploy remainder of proximal stent: turn second stent release knob ¼
turn counterclockwise and then steadily pull knob and attached wire
from handle.
WARNING: DO NOT push or pull the delivery system after complete
deployment of the proximal stent to avoid inadvertent disconnection of
the polymer fill connector from the implant.
WARNING: To allow conformance of the stent graft to the native anatomy
when significant angulation is present, ensure an extra stiff wire is not
inside the aortic body during injection of the fill polymer.

17
Fill Polymer Preparation
1 Using sterile technique, place fill polymer kit and autoinjector onto
sterile field.
2 Open both fill kit syringe valves, and transfer contents between
syringes for a minimum of 20 full strokes. Completely transfer contents
into syringe with green band (fill syringe) and close both stopcocks.
Remove tear tab and disconnect fill syringe.
Note: If voiding air or any fill polymer from the fill syringe prior to closing
the stopcocks, the following minimum volume of fill polymer must
remain in the fill syringe to completely fill the stent graft.
Aortic Body Stent Graft
Diameter
Fill Syringe Volume
20 mm ≥7 ml
23 mm ≥8 ml
26 mm ≥9 ml
29 mm ≥11 ml
34 mm ≥13 ml
3 Note the time, or start a timer, when mixing is complete.
WARNING: Should an error occur in the timing, mixing, or transfer,
discard the fill polymer. Start mixing with a new fill polymer kit.
WARNING: Injection of the fill polymer should occur immediately after
mixing. If injection of the fill polymer has been delayed 3 or more minutes
after mixing, discard the fill polymer. Start mixing with a new fill polymer
kit.
Fill Polymer Injection
WARNING: DO NOT push or pull the delivery system after complete
deployment of the proximal stent to avoid inadvertent disconnection of
the polymer fill connector from the implant.
1 Remove green fill cap from polymer injection port on handle.
2 Attach fill syringe to polymer injection port on handle.
3 Firmly hold filled syringe stationary and push autoinjector over plunger,
ensuring that the autoinjector is placed over the “shoulders” of the
syringe body. Rotate autoinjector 90 degrees to lock (confirmed with an
audible “click”). Fill polymer will begin filling aortic body.
4 Using fluoroscopy, intermittently observe filling of graft with radiopaque
fill polymer.
WARNING: During fill polymer injection and cure, observe the delivery
system and/or syringe for inadvertent disconnection or fill polymer spill.
Radiopaque marker movement and/or rapid emptying of the fill polymer
syringe may be indications that the fill polymer is not filling the stent
graft. If this is observed, immediately disconnect the Autoinjector from
the fill polymer syringe.
WARNING: Patients who experience hypersensitivity reactions during the
procedure should be managed in accordance with standard
recommendations for treatment of patients with radiocontrast agent

18
allergies (e.g., antihistamines, corticosteroids, adrenaline).
Contralateral Limb Insertion and Deployment
1 Cannulate the contralateral lumen with a guidewire.
CAUTION: Confirm cannulation of graft true lumen to ensure accurate
placement of the contralateral limb.
2 Use imaging techniques to locate the contralateral internal iliac artery.
3 Confirm appropriate size (diameter and length) of iliac limb selected for
contralateral side, and prepare iliac limb delivery system (per above
instructions).
4 Maintaining guidewire position, remove angiographic catheter and
introducer sheath from contralateral access site (if applicable).
5 Load iliac limb delivery system over guidewire. Confirm there is no
tension on the aortic body stent graft prior to or during placement of the
iliac limb within the aortic body.
6 Using continuous fluoroscopic guidance, insert iliac limb delivery
system into vasculature until proximal iliac limb radiopaque markers
align with the ½ ring of the aortic body (most proximal ring).
7 Confirm distal iliac limb radiopaque markers are at the appropriate
location and that the iliac limb is in the contralateral lumen.
8 Retract sheath to deploy iliac limb while maintaining catheter handle
position.
9 Maintain position of sheath and use catheter handle to retract nosecone to
sheath.
10 Remove iliac limb delivery system from vasculature while maintaining
guidewire position.
Re-insert angiographic catheter and advance to suprarenal aorta.
Aortic Body Catheter De-Mate and Withdrawal
1 A minimum of 20 minutes after completion of fill polymer mixing,
disconnect autoinjector from aortic body delivery system, holding the
autoinjector tightly to control its force once it is unlocked from the
shoulders of the syringe.
WARNING: Do not disconnect the delivery system before 20
minutes to prevent potential release of fill polymer.
2 Release catheter from aortic body: turn third release knob ¼ turn
counterclockwise and then steadily pull knob and attached wire from
handle.
3 Using fluoroscopy, carefully withdraw inner catheter until fill lumen
disengages from stent graft. The radiopaque marker band on the

19
polymer fill port should move away from stent graft.
WARNING: If resistance is encountered during catheter
withdrawal, STOP. Identify cause of resistance and resolve prior
to continuing withdrawal. Catheter rotation may be sufficient to
overcome resistance.
4 While maintaining guidewire position, use catheter handle to retract
nosecone to tip of delivery system outer sheath.
5 Remove the aortic body delivery system.
Ipsilateral Limb Insertion and Deployment
1 Follow the appropriate procedural steps for ipsilateral limb deployment
as previously described in Contralateral Limb Insertion and
Deployment.
Deployment Completion
1 Verify aneurysm exclusion. Perform angiography from proximal landing
site to distal landing sites.
2 Although not required as part of the implant procedure, angioplasty
balloons of appropriate sizes (diameter equivalent to the vessel size)
may be used to improve aneurysm exclusion or to improve the stent
graft lumen.
WARNING: It is important to accurately size the balloons and
not over-inflate within the stent graft. Carefully follow the
balloon manufacturer’s inflation parameters described in the
product labeling.
•Prepare balloon catheters and other adjunctive devices to be
used according to the manufacturer’s Instructions For Use.
•Iliac limb/ aortic body junction: The junction may be ballooned
using a 12 mm non-compliant balloon, inflated to no more than 5
atm. The “kissing balloon” technique may be utilized at this
location.
•Distal iliac: The area may be ballooned using a non-compliant
balloon the same diameter as the distal iliac diameter.
WARNING: Do not balloon the iliac limb/ aortic body junction or
the distal iliac with a compliant balloon.
•After removal of the angiographic catheter (if present), the proximal
aortic body may be ballooned before delivery system removal with a
compliant balloon of the same diameter as the proximal aortic
diameter. A noncompliant balloon may be used in the aortic body
only after the delivery system is removed.
CAUTION: It is not recommended to balloon prior to 15 minutes after
completion of the final polymer mix. Ballooning prior to 15 minutes
could damage the sealing rings.
3 If no other interventions are required and aneurysm exclusion has
been verified, remove the angiographic catheter and maintain
guidewire position(s). If extension of the iliac is required, proceed
with the Iliac Extension Insertion and Deployment steps below.
4 Remove guidewires and introducer sheaths. Close vascular access.

20
Iliac Extension Insertion and Deployment
1 Using the radiopaque markers on the distal end of the iliac limb as a
target and using standard endovascular techniques, cannulate the iliac
limb lumen with a guidewire (if necessary).
2 Determine the amount of extension required. If 20 mm or less, use of a
straight distal extension is recommended. Refer to the table below for
the distal straight extension diameters (Iliac Extension Sizes, 45 mm
length) recommended for use with each iliac limb distal diameter.
Iliac Extension Size
(Straight, 45 mm length)
1
0
1
2
14 1
6
1
8
2
2
Iliac Limb
Distal
Diameter
1
0
X X X
1
2
X X X
1
4
X X X
1
6
X X X
1
8
X X
2
2
X
20 mm Maximum allowable
extension
3 To use an iliac limb as an extension, refer to the table below. Based on
the iliac limb distal diameter and the amount of extension required,
select the appropriate extension component length.
Iliac Limb
Distal
Diameter
(mm)
Amount of
Extension
Required (mm)
Extension
Component
Length (mm)
10
12
Up to 50 80
51 - 70 100
71 - 90 120
91 - 110 140
14
16
18
22
Up to 10 ** 80 **
11 - 20 100
21 - 40 120
41 - 60 140
** Diameter of extension must be ≥distal diameter of iliac limb
4 Prepare the extension delivery system (per above instructions).
5 Maintaining guidewire position, remove angiographic catheter and
introducer sheath from access site (if applicable).
6 Load the delivery system over the guidewire.