Skip to content

Ovation Prime Abdominal Stent Graft System Aortic Body (REF TV-AB2080-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
2
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M701TVAB2080E1), received between Jan 1, 2017 and Jul 5, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • DeathJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN IN THE FLANK AND ILIAC FOSSA. THE PATIENT HAD AN EXPLANT OF THE DEVICE DUE TO AN INFECTION POSSIBLY CAUSED BY THE PATIENT CONTRACTING MALARIA. THE FINAL PATIENT STATUS WAS REPORTED AS BEING ALIVE AND WELL.

    Patient problems: Unspecified Infection

    MAUDE report 14918337 ↗
  • InjuryJan 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 YEAR POST-OPERATIVE CT SHOWED THE PRESENCE OF INFLAMMATION OF THE AORTA WITH POSSIBLE INFECTION AND ANEURYSM ENLARGEMENT. THE PATIENT IS REPORTED TO HAVE PREVIOUSLY UNDERWENT HERNIA REPAIR SEVERAL WEEKS BEFORE. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE; AND CULTURES WERE TAKEN INTRAOPERATIVELY DURING THE EXPLANT PROCEDURE AND THE RESULTS REPORTED AS GRAM POSITIVE COCCI. THE PROCEDURE TIME IS REPORTED PROLONGED WITH UNITS OF BLOOD PROVIDED. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE ICU FOR RECOVERY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 6217009 ↗

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

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