Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1412140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M701TVIL1412140J1), received between May 3, 2017 and Jan 6, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2022Off-Label Use; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE A TYPE IA ENDOLEAK, AND A TYPE IB ENDOLEAK WERE IDENTIFIED DURING ROUTINE FOLLOW-UP. SUCCESSFUL REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN PALMAZ (NON-ENDOLOGIX) TO TREAT THE TYPE IA ENDOLEAK AND AN OVATION EXTENDER TO TREAT THE TYPE IB ENDOLEAK. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 13179247 ↗
• InjuryApr 20, 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 SYSTEM. APPROXIMATELY (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK, A DISTAL COMMON ILIAC ARTERY DISSECTION, AND ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER). THE PATIENT IS IN GOOD CONDITION, AND THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. NOTE: THE PATIENT HAS SIGNIFICANT PAD (PERIPHERAL ARTERIAL DISEASE) WITH NEARLY OCCLUDED COMMON ILIAC ARTERIES.

  Patient problems: Aneurysm; Failure of Implant; Vascular Dissection

  MAUDE report 11697134 ↗
• InjuryJul 24, 2019Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. THE PHYSICIAN FOUND THAT THE OVATION ILIAC LIMB ON THE PATIENT'S LEFT SIDE HAD PULLED OUT OF THE ILIAC ARTERY AND WAS IN THE AAA WITH A TYPE IB ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL ILIAC LIMB OVATION DEVICES ON (B)(6) 2019. THE PATIENT IS REPORTEDLY IN STABLE CONDITION AND A GOOD SEAL WAS ACHIEVED POST RE-INTERVENTION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8823634 ↗
• InjuryJul 3, 2018Partial Blockage; Partial Blockage

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE INITIAL PROCEDURE, THERE WAS A POLYMER LEAK REPORTED. ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT HAD AN OCCLUDED LIMB AND AN ANGION WAS GOING TO BE PERFORMED. PATIENT RECEIVED A SECONDARY ON (B)(6) 2018 TO ADD AN EXTENDER TO THE RIGHT LIMB TO COVER DISSECTION PLANE. FLOW WAS RE ESTABLISHED, BUT FRESH CLOT FORMED UPON CUT DOWN. PATIENT WAS RECEIVING TPA DRIP IN THE SFA OVERNIGHT. AS OF THIS REPORT, NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7658746 ↗
• InjuryJun 18, 2018Unintended Movement; Unintended Movement

  ENDOLOGIX BECAME AWARE OF A LEFT LIMB PULLING UP INTO THE ABDOMINAL AORTIC ANEURYSM SAC ON (B)(6) 2018 AS REPORTED BY PHYSICIAN (B)(6) AT (B)(6) MEDICAL CENTER. THE DATE OF EVENT IS ALSO (B)(6) 2018 BASED ON ROUTINE FOLLOW-UP CTA SCAN WHICH DIAGNOSED THE REPORTED MOVEMENT OF THE DISTAL ATTACHMENT SEAL IN THE LEFT COMMON ILIAC. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN OVATION IX MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS ON (B)(6) 2017 BY THE REPORTING PHYSICIAN. DURING RE-INTERVENTION, THE PATIENT WAS TREATED BY IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB ON (B)(6) 2018 BY PHYSICIAN (B)(6), WHO DETERMINED THAT THE LEFT COMMON ILIAC WAS TOO DISEASED TO LAND, TRAY AND SEAL IN. THE LEFT INTERNAL WAS DISEASED AND STENOTIC AT ITS ORIGIN AS WELL. THE PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 7609372 ↗
• InjuryMay 22, 2018Occlusion 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 FOLLOW UP FOR AN UNKNOWN REASON WHERE PHYSICIAN OBSERVED AN INCREASE IN ANEURYSM SIZE AT THE LEFT ILIAC AND A DECREASE IN THE FLOW LUMEN OF THE LEFT ILIAC LIMB. THE PATIENT IS CURRENTLY STABLE AND NO PLANS FOR RE-INTERVENTION HAVE BEEN MADE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 7533781 ↗
• InjuryMay 3, 2017Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 9 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF A TYPE 1B ENDOLEAK AT THE RIGHT ILIAC. A RE-INTERVENTION WAS PERFORMED TO IMPLANT AN OVATION ILIAC LIMB EXTENSION EXTENDING THE SEAL INTO THE RIGHT COMMON ILIAC ARTERY, SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 6542827 ↗