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Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1416160-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
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M701TVIL1416160J1), received between Jul 10, 2019 and Aug 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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

  • Complete Blockage1
  • Improper or Incorrect Procedure or Method1
  • Insufficient Device Problem Information1
  • Material Deformation1
  • Off-Label Use1

Patient problems

  • Failure of Implant1
  • No Code Available1
  • Stenosis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 23, 2021Complete Blockage; Complete Blockage

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT GRAFT SYSTEM. APPROXIMATELY FOURTEEN (14) MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED TO ROUTINE FOLLOW-UP WITH LEG PAIN. OCCLUSION CAUSED BY THROMBUS IN THE RIGHT OVATION IX ILIAC LIMB WAS IDENTIFIED. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS REPORTEDLY DOING WELL.

    Patient problems: Failure of Implant

    MAUDE report 12356417 ↗
  • InjuryJul 30, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE IB ENDOLEAK WAS DETECTED DURING ROUTINE FOLLOW-UP. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL ILIAC LIMB OVATION IX DEVICES ON (B)(6) 2019. THE PATIENT IS REPORTEDLY DOING WELL AND THE LEAK WAS CONFIRMED RESOLVED POST RE-INTERVENTION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Patient problems: No Code Available

    MAUDE report 8843148 ↗
  • InjuryJul 10, 2019Material Deformation; Material Deformation

    THE PATIENT WAS INITIALLY TREATED WITH AN OVATION IX ILIAC LIMB AND AFX2 SYSTEM, WHICH IS CURRENTLY OUTSIDE THE INDICATIONS FOR USE. THE PATIENT UNDERWENT A PREVIOUS RE-INTERVENTION FOR A REPORTED TYPE IB ENDOLEAK (REFERENCE 3008011247-2019-00067) WHERE AN ADDITIONAL OVATION IX LIMB WAS IMPLANTED. APPROXIMATELY 2-MONTHS POST RE-INTERVENTION FOR THE TYPE IB ENDOLEAK THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP AND A COMPUTED TOMOGRAPHY WAS COMPLETED REVEALING A SUSPECTED KINK IN THE DEVICE AND NARROWING WITH DIMINISHED FLOW. THE PHYSICIAN TREATED THE PATIENT WITH A NON-ENDOGLOGIX WALL STENT SUCCESSFULLY RESOLVING THE KINK. THE PATIENT IS REPORTED AS STABLE AND WILL CONTINUE TO BE MONITORED.

    Patient problems: Stenosis

    MAUDE report 8777931 ↗

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Sources and updates

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