Ovation iX Iliac Stent Graft Iliac Extension (REF TV-EX181845-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 M701TVEX181845J1), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Lack of Effect” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Lack of Effect1

Patient problems

Clinical Endoleak1

Recent adverse event reports

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

InjuryMar 22, 2024Lack of Effect; Lack of Effect
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015. ADDITIONALLY, (3) THREE OVATION IX ILIAC EXTENDERS WERE IMPLANTED ON (B)(6) 2016 FOR AN UNKNOWN REASON. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY NINE (9) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE LEFT LEG OF THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE SEPARATED FROM ONE OF THE OVATION IX ILIAC EXTENDERS (CLASSIFIED AS A TYPE 3A ENDOLEAK). THE PHYSICIAN ELECTED TO RELINE THE PREVIOUSLY IMPLANTED STENT GRAFTS WITH AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT, AN OVATION IX ILIAC LIMB AND AN OVATION IX ILIAC EXTENDER ON (B)(6)2024 TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST-SECONDARY PROCEDURE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR#: 3011063223-2024-00008. NOW APPROXIMATELY SEVEN (7) YEARS POST IMPLANT OF THE OVATION IX EXTENDERS, AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY OCCURRED. THE TYPE
Patient problems: Clinical Endoleak
MAUDE report 18958025 ↗

Device details

UDI-DI	`M701TVEX181845J1`
Brand	Ovation iX Iliac Stent Graft
Model	Iliac Extension
Catalog no.	TV-EX181845-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.

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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.

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