Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL141280-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M701TVIL141280J1), received between Aug 22, 2016 and Dec 14, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE MAIN BODY AND OVATION IX ILIAC LIMBS WERE IMPLANTED IN EACH SIDE. AN ADDITIONAL OVATION IX ILIAC LIMB WAS IMPLANTED ON THE RIGHT SIDE. IT WAS REPORTED THAT SEVEN (7) HOURS AFTER THE IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF RIGHT LOWER LIMB PAIN AT REST. A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED THERE WAS RIGHT LIMB OCCLUSION (OVATION IX ILIAC LIMB). THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION AND THROMBUS WAS REMOVED FOLLOWED BY IMPLANT OF A MISAGO/TERUMO (NON-ENDOLOGIX) STENT TO SUCCESSFUL RESOLVE THE EVENT. TWO (2) DAYS AFTER THIS INTERVENTION THE PAIN WAS RESOLVED. THE PATIENT WAS DISCHARGED AT THE THIRD DAY POST PROCEDURE WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Failure of Implant; Obstruction/Occlusion; Pain

  MAUDE report 15982917 ↗
• InjuryOct 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT, FOLLOWING A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN, A TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC AND A POSSIBLE TYPE 2 ENDOLEAK (NON-DEVICE-RELATED FAILURE) WERE IDENTIFIED. THE PATIENT IS SCHEDULED FOR RE-INTERVENTION. ADDITIONAL INFORMATION RECEIVED INDICATING THE SCHEDULED RE-INTERVENTION HAS BEEN CANCELLED.

  Patient problems: Failure of Implant

  MAUDE report 10755713 ↗
• InjurySep 29, 2017Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP WHERE PHYSICIAN OBSERVED ONE OF THE ILIAC LIMBS IS OCCLUDED. THE ANATOMY WAS NOTED TO BE EXTREMELY TORTUOUS. THE PATIENT IS ASYMPTOMATIC AND THERE ARE CURRENTLY NO PLANS FOR RE-INTERVENTION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion; Stenosis

  MAUDE report 6904627 ↗
• InjuryAug 22, 2016Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  AN AFX ABDOMINAL STENT GRAFT WITH OVATION IX ILIAC LIMBS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A LONGER THAN RECOMMENDED ILIAC LIMB STENT GRAFT WAS DEPLOYED INADVERTENTLY COVERING THE RIGHT INTERNAL ILIAC ARTERY. A BALLOON EXPANDABLE STENT WAS DEPLOYED IN THE RIGHT INTERNAL ILIAC ARTERY FOLLOWED BY THE PLACEMENT OF ANOTHER ILIAC LIMB STENT GRAFT TO MAINTAIN LUMINAL PATENCY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5895335 ↗