Ovation iX Iliac Stent Graft Iliac Extension (REF TV-EX161645-J)Recalls & reported problems

Endologix LLC · The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft 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 with the Ovation iX Iliac Stent Graft 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 iX Iliac Stent Graft (66)

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 M701TVEX161645J1), received between May 10, 2018 and May 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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

Failure To Adhere Or Bond1
Leak/Splash1
Material Deformation1

Patient problems

Failure of Implant1

Recent adverse event reports

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

InjuryMay 10, 2018Failure To Adhere Or Bond; Leak/Splash; Material Deformation; Failure To Adhere Or Bond; Leak/Splash; Material Deformation
THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN OVATION MAIN BODY, EXTENDER, AND THREE (3) ILIAC LIMBS ON (B)(6) 2018. DURING A FOLLOW-UP NON-CON CT SCAN, A TYPE 1A ENDOLEAK WAS OBSERVED. ENDOLOGIX BECAME AWARE OF A COMPLAINT AGAINST OUR DEVICE ON (B)(6) 2018. THE PATIENT IS DOING WELL, AND A FOLLOW-UP CONTRAST CT SCAN IS PLANNED FOR 2 MONTHS FROM NOW.
Patient problems: Failure of Implant
MAUDE report 7503908 ↗

Device details

UDI-DI	`M701TVEX161645J1`
Brand	Ovation iX Iliac Stent Graft
Model	Iliac Extension
Catalog no.	TV-EX161645-J
Company	Endologix LLC
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	Not in Commercial Distribution
Record updated	Dec 17, 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