Ovation Prime Abdominal Stent Graft System Iliac Limb (REF TV-IL1416140-E)Recalls & reported problems

Trivascular, Inc. · The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector. · Class 3 · Implant

All models of Ovation Prime Abdominal Stent Graft System (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M701TVIL1416140E1), received between Aug 15, 2015 and Aug 15, 2015 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Occlusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 15, 2015Adverse Event Without Identified Device or Use Problem
AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS READMITTED TO THE HOSPITAL 3 WEEKS POST-OP WITH A COMPLETE OCCLUSION OF THE RIGHT ILIAC LIMB STENT GRAFT AND NARROWING AT THE LEVEL OF THE AORTIC BODY STENT GRAFT SEALING RINGS. A RE-INTERVENTION WAS COMPLETED IN WHICH A FEM-FEM BYPASS WAS PERFORMED TO SUCCESSFULLY RESTORE BLOOD FLOW TO THE OCCLUDED ILIAC ARTERY FOLLOWED BY THE PLACEMENT OF A BALLOON EXPANDABLE STENT AT THE LEVEL OF THE SEALING RINGS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.
Patient problems: Occlusion
MAUDE report 5005993 ↗

Device details

UDI-DI	`M701TVIL1416140E1`
Brand	Ovation Prime Abdominal Stent Graft System
Model	Iliac Limb
Catalog no.	TV-IL1416140-E
Company	Trivascular, Inc.
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 24, 2025

Device type (GMDN): Aortoiliac endovascular stent-graft

A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

Endurant® IIs ESBF2814C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls34 deaths254 reports
Endurant® IIs ESBF3214C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls19 deaths173 reports
Endurant® IIs ESBF3614C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
1 recall37 deaths214 reports
Endurant® IIs ESBF2514C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls18 deaths136 reports
Endurant® IIs ESBF2314C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls9 deaths60 reports
RelayPro Thoracic Stent-Graft System 28-N4-34-154-34U
Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
3 recalls7 reports
Vela Proximal Endograft System A34-34/C100-O20 V
Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
3 deaths152 reports
Endurant® II ETCF2828C49E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls7 deaths44 reports

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page