Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1418100-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M701TVIL1418100J1), received between Mar 3, 2016 and Nov 10, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryNov 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM (LEFT LIMB: LOT: FS031221-09, RIGHT LIMB: LOT: FS020121-29) ON (B)(6) 2022. REPORTEDLY, ON (B)(6) 2022, THE PATIENT FELT PARALYZED ON THEIR RIGHT LOWER LIMB, AND VISITED THE LOCAL HOSPITAL ON THE NEXT DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL. REPORTEDLY, THE PATIENT EXPERIENCED BRAIN INFARCTION AND UNKNOWN TREATMENT WAS PROVIDED. THE CAUSE OF THE BRAIN INFARCTION IS UNKNOWN. THE PATIENT WAS REPORTED TO BE BETTER THE FOLLOWING MONTH.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 18114375 ↗
• InjuryMay 30, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH ABDOMINAL AND BACK PAIN. THE PATIENT HAD BEEN LOST TO FOLLOW UP AND WAS LAST SEEN IN 2019. CURRENTLY THE AAA MEASURES 18CM AND THERE IS A CONTAINED RUPTURE DUE TO A RIGHT COMMON ILIAC ARTERY (CIA) TYPE 1B ENDOLEAK. THE PHYSICIANS ELECTED TO PERFORM A SECONDARY INTERVENTION PROCEDURE AND PLACED A 16X27X140 GORE EXCLUDER (NON-ENDOLOGIX) LIMB WHICH SUCCESSFULLY RESOLVED THIS EVENT. IT WAS NOTED THAT THE PATIENT RECEIVED ONE UNIT OF BLOOD AND WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) POST OPERATIVELY. THE NEXT DAY THE PATIENT WAS TRANSFERRED TO THE TELEMETRY FLOOR AND WAS DISCHARGED ONE DAY LATER. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST COILING OF THE INTERNAL MESENTERIC ARTERY OCCURRED (DATE UNKNOWN) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE COILING WAS DISCOVERED DURING A REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN DATED 05/08/2023.

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak; Rupture

  MAUDE report 17020506 ↗
• InjuryMay 10, 2022Off-Label Use; Separation Problem; Off-Label Use; Separation Problem

  THE PATIENT WAS IMPLANTED WITH THE AFX2 BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB, AFX LIMB STENT GRAFT, AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY (3) THREE YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT WAS IDENTIFIED WITH SAC GROWTH IN RIGHT COMMON ILIAC (RCIA) AND A 3A ENDOLEAK WITH SEPARATION BETWEEN THE OVATION IX ILIAC LIMB AND THE AFX2 BIFURCATED STENT GRAFT. A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN IMPLANTED (2) TWO AFX LIMB STENT GRAFTS TO RESOLVED THE ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL POST RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14349995 ↗
• InjurySep 17, 2021Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH MIGRATION OF THE LEFT ILIAC LIMB AND A TYPE 1B ENDOLEAK. THE PHYSICIAN SUCCESSFULLY TREATED THE PATIENT BY IMPLANTING TWO (2) OVATION IX ILIAC LIMBS AND THE PATIENT IS REPORTEDLY IN GOOD CONDITION. NOTE: THE PATIENT'S LEFT ILIAC ARTERY IS SHORT AND TAPERED. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 2 ENDOLEAK (NON-DEVICE-RELATED) OF THE LUMBAR ARTERY.

  Patient problems: Failure of Implant

  MAUDE report 12491341 ↗
• InjuryFeb 27, 2017Occlusion Within Device; Improper or Incorrect Procedure or Method; Malposition of Device; Occlusion Within Device; Improper or Incorrect Procedure or Method; Malposition of Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 5 MONTH POST-OPERATIVE CT IMAGING SHOWED THE PRESENCE OF AN OCCLUSION OF THE RIGHT ILIAC LIMB STENT GRAFT DUE TO THE MALPOSITION OF THE ILIAC LIMB STENT GRAFTS WITHIN THE LEG OF THE AORTIC BODY STENT GRAFT IN COMBINATION WITH THE PRESENCE OF SIGNIFICANT INFRARENAL AORTIC ANGULATION. A RE-INTERVENTION IS PLANNED AT A LATER DATE TO TREAT THE OCCLUDED LIMB. 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: Occlusion

  MAUDE report 6363012 ↗
• InjuryMar 3, 2016Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. THE 1 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF A LEFT INTERNAL ILIAC ARTERY OCCLUSION DUE TO PARTIAL COVERAGE OF THE INTERNAL ILIAC ARTERY WITH THE DISTAL ASPECT OF THE ILIAC LIMB STENT GRAFT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5478483 ↗