Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1416140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M701TVIL1416140J1), received between Dec 13, 2017 and Dec 3, 2021 — classified as 6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A SMALL TYPE 3B ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS IDENTIFIED. SUCCESSFUL REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN OVATION IX ILIAC LIMB. THE PATIENT WAS REPORTED TO BE WELL POST-REINTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12928541 ↗
• InjuryOct 25, 2021Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS. APPROXIMATELY FOUR (4) MONTHS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH ABDOMINAL PAIN. AFTER AN ANGIOGRAM, A TYPE 1B ENDOLEAK WAS IDENTIFIED AS WELL AS BOTH ILIAC LIMBS HAD MIGRATED BACK INTO THE ABDOMINAL ANEURYSM. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT ONE (1) ADDITIONAL OVATION IX LIMB IN EACH ILIAC. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12691696 ↗
• InjuryMay 19, 2021Device-Device Incompatibility; Insufficient Device Problem Information; Device-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 EIGHT (8) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL OVATION IX ILIAC LIMB STENT GRAFTS ON (B)(6) 2021. THE ENDOLEAK WAS SUCCESSFULLY SEALED AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 11846611 ↗
• InjuryApr 8, 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 IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A NON- ENDOLOGIX (MEDTRONIC, THORACIC CUFF) PROXIMAL STENT GRAFT, AN OVATION IX EXTENDER AND TWO (2) OVATION ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF LABEL). DURING THE ROUTINE 1 MONTH FOLLOW UP VISIT ((B)(6) 2018), A TYPE 3A ENDOLEAK BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE LEFT OVATION ILIAC LIMB (16X140) WAS IDENTIFIED AND LATER CONFIRM WITH AN ANGIOGRAM ((B)(6) 2018). A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER OVATION ILIAC LIMB TO BRIDGE THE GAP BETWEEN THE BIFURCATED STENT GRAFT AND THE LEFT OVATION ILIAC LIMB. A SMALL LEAK WAS STILL PRESENT POST- SECONDARY PROCEDURE. APPROXIMATELY 1 MONTH LATER ((B)(6) 2018), ANOTHER INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO IMPLANT A NON- ENDOLOGIX (PALMAZ) STENT. A SMALL LEAK WAS STILL PRESENT POST INTERVENTION BUT THE PHYSICIAN DECIDED TO MONITOR THE PATIENT AS THERE WAS NO SAC GROWTH. THE PATIENT WAS REPORTED AS BEING AS BEING STABLE POST INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8492214 ↗
• InjuryOct 10, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS EXPERIENCING CLAUDICATION, AND UPON DIAGNOSTIC ANGIO, WHAT APPEARS TO BE THROMBUS OR EXTRINSIC COMPRESSION ON THE LEFT LIMB WAS OBSERVED. ON (B)(6) 2018, OVATION IX LIMB EXTENSIONS WERE IMPLANTED IN THE LEFT AND RIGHT ILIAC LIMBS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Claudication; Failure of Implant; Occlusion; Stenosis

  MAUDE report 7951027 ↗
• InjuryDec 13, 2017Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A FOLLOW UP APPROXIMATELY 2 YEARS POST INDEX PROCEDURE WHERE PHYSICIAN NOTICED A POTENTIAL TYPE 3B ENDOLEAK OF THE LIMB. THERE ARE CURRENTLY NO PLANS FOR RE-INTERVENTION AND AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7115022 ↗