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Ovation Prime Abdominal Stent Graft System Iliac Limb (REF TV-IL1414140-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
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M701TVIL1414140E1), received between Sep 28, 2020 and Aug 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

  • Insufficient Device Problem Information2
  • Device-Device Incompatibility1

Patient problems

  • Failure of Implant2
  • Thrombus1

Recent adverse event reports

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

  • InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (6) SIX YEARS AFTER THE POST-INITIAL PROCEDURE, A TYPE 2 ENDOLEAK AND A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IS PLANNING TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENTS CURRENT CONDITION IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 12350573 ↗
  • InjurySep 28, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, FIVE (5) OVATION PRIME ILIAC LIMBS, AND ONE (1) OVATION PRIME EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). ADDITIONALLY, A GENISIS L (NON-ENDOLOGIX) STENT WAS IMPLANTED. APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, PATIENT EXPERIENCED LEFT LOWER EXTREMITY CLAUDICATION. LEFT LIMB OCCLUSION WAS IDENTIFIED. PATIENT WAS TREATED WITH STENTING OF THE RIGHT EXTERNAL ILIAC ARTERY (TYPE OF STENT NOT REPORTED) AND FEM-FEM BYPASS GRAFT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

    Patient problems: Failure of Implant; Thrombus

    MAUDE report 10596715 ↗

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Sources and updates

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