Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1410160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M701TVIL1410160J1), received between Aug 8, 2019 and Jul 7, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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

Recent adverse event reports

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

• InjuryJul 7, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (5) FIVE YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING (2) TWO OVATION IX ILIAC LIMB STENT-GRAFTS. THE ENDOLEAK WAS SUCCESSFULLY SEALED AND THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12129407 ↗
• InjuryJan 8, 2021Partial Blockage; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Partial Blockage; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE INITIAL IMPLANT PROCEDURE AND POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION DUE TO A SUSPECTED POLYMER LEAK AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. REFERENCE MFR. REPORT # 3008011247-2018-00109 FOR THIS PREVIOUS REPORTED EVENT TO THE PATIENT. NOW APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE RIGHT-SIDE LIMB IS SIGNIFICANTLY STENOSED WITH INTRA-GRAFT THROMBUS. NO ENDOLEAK WAS IDENTIFIED AND THE AAA REGRESSED AND APPEARS SEALED. RE-INTERVENTION WAS COMPLETED ON (B)(6) 2020 WITH THE IMPLANT OF TWO (2) OVATION IX ILIAC LIMBS. THE PATIENT IS DOING WELL POST PROCEDURE.

  Patient problems: Stenosis; Thrombus

  MAUDE report 11143521 ↗
• InjuryAug 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT; INITIAL PROCEDURE INCLUDED COILING WITH COVERING OF THE RIGHT-SIDE HYPOGASTRIC ARTERY DUE TO AN ANEURYSMAL ILIAC AND TORTUOSITY OF BOTH ILIACS. APPROXIMATELY NINE (9) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE LIMB FLOW REDUCTION AND HIGH VELOCITY, MONOPHASIC (OCCLUSION) OF THE RIGHT LIMB DETECTED BY ULTRASOUND. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THERE WAS NO VISIBLE FLOW REDUCTION OR OCCLUSION OBSERVED ON THE COMPUTERIZED TOMOGRAPHY SCAN FROM (B)(6) 2019; THEREFORE, THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient; Occlusion

  MAUDE report 8876316 ↗