Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1418120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1418120J1), received between Nov 17, 2016 and Aug 14, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2020. AFTER THE ALTO MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS WERE IMPLANTED, THERE WAS AN INTRAOPERATIVE TYPE IA ENDOLEAK. THE TYPE IA ENDOLEAK WAS SEALED WITH THE IMPLANT OF A NON-ENDOLOGIX PALMAZ STET GRAFT. ON (B)(6) 2023, ROUTINE FOLLOW-UP IDENTIFIED A TYPE IB ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2023, WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB SEALING THE TYPE IB ENDOLEAK ON THE LEFT SIDE. REPORTEDLY, THE PATIENT WAS STABLE POST REINTERVENTION AND DISCHARGED FROM THE HOSPITAL. AFTER SUBMISSION OF THE INITIAL REPORT, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST TYPE IA ENDOLEAK (COILING AND ANGIOPLASTY 07/25/2023) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE IA ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE OPERATIVE REPORT DATED 08/25/2023. ADDITIONALLY, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST ADDITIONAL ENDOVASCULAR PROCEDURE OCCURRED (PERCUTANEOUS COILING OF ENDOLEAK IN 2022) THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 17542062 ↗
• InjuryApr 26, 2022Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED A TYPE IB ENDOLEAK FROM THE RIGHT ILIAC LIMB. REPORTEDLY AT THE INITIAL IMPLANT, COVERAGE WAS VERY SHORT (LESS THAN 10MM). THE OVATION IX ILIAC LIMB HAS RETRACTED INTO THE ANEURYSM SAC. REINTERVENTION IS TO BE SCHEDULED. THE PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14210122 ↗
• InjuryDec 6, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A JUNCTION ENDOLEAK (CATEGORIZED AS A TYPE 3A ENDOLEAK) WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB STENT GRAFT TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 12940512 ↗
• InjuryMar 10, 2020Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH THE RIGHT ILIAC LIMB SLIPPED OUT OF THE ILIAC AND RESTING IN THE AORTA WITH NO ENDOLEAK DETECTED. THE PHYSICIAN PLANS TO RELINE WITH AN ADDITIONAL ILIAC LIMB DEVICE AND WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9814256 ↗
• InjuryJul 10, 2019Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL AORTIC STENT GRAFT SYSTEM. APPROXIMATELY EIGHT (8)-MONTHS POST-OP THE PATIENT PRESENTED ON AN UNKNOWN DATE FOR A ROUTINE FOLLOW-UP. A TYPE IIIB ENDOLEAK WAS DETECTED BY ANGIOGRAM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT; IMPLANTING AN ADDITIONAL OVATION IX LIMB. THE FINAL ANGIOGRAM CONFIRMED THE ENDOLEAK WAS RESOLVED. THE PATIENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT REFUTED THE REPORTED TYPE IIIB ENDOLEAK; RATHER, THERE WAS EVIDENCE OF A TYPE IB ENDOLEAK AT THE LEFT COMMON ILIAC ARTERY.

  Patient problems: Failure of Implant

  MAUDE report 8778589 ↗
• InjuryFeb 23, 2017Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE LEFT ILIAC LIMB STENT GRAFT IN THE PRESENCE OF SIGNIFICANT TORTUOSITY AND CALCIUM IN THE LEFT COMMON ILIAC ARTERY, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, AND EXTRAVASATION WAS NOTED OUTSIDE THE LEFT ILIAC LIMB STENT GRAFT INDICATIVE OF A POTENTIAL RUPTURE OF THE LEFT COMMON ILIAC ARTERY. IT WAS NOTED THAT A LAPAROTOMY WAS PERFORMED TO EXPLORE THE ORIGIN OF THE EXTRAVASATION; HOWEVER, THE ORIGIN COULD NOT BE CONFIRMED. AN ADDITIONAL ILIAC LIMB EXTENSION WAS PLACED EXTENDING DOWN TO THE EXTERNAL ILIAC ARTERY, FOLLOWED BY THE PLACEMENT OF A BALLOON EXPANDABLE STENT WITHIN THE LEFT ILIAC LIMB STENT GRAFT SUCCESSFULLY RESOLVING THE EXTRAVASATION. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Extravasation; Rupture

  MAUDE report 6353060 ↗
• InjuryFeb 9, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED 23 DAYS POST-OPERATIVE WITH NUMBNESS IN THE RIGHT LEG AND A REDUCED PALPABLE PULSE. THE POST OPERATIVE CT SHOWED A STENOSIS OF THE RIGHT ILIAC LIMB STENT GRAFT WITH EVIDENCE OF COMPRESSION OF THE RIGHT ILIAC LIMB STENT GRAFT IN THE PRESENCE OF SIGNIFICANT AORTIC NARROWING AT THE LEVEL OF THE NATIVE AORTIC BIFURCATION. A RE-INTERVENTION IS PLANNED AT A LATER DATE TO PLACE A BALLOON EXPANDABLE STENT WITHIN THE COMPRESSED ILIAC LIMB STENT GRAFT. AS OF THE DATE OF THIS REPORT, THE RE-INTERVENTION HAS NOT BEEN SCHEDULED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Stenosis

  MAUDE report 6314487 ↗
• InjuryNov 17, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 1.5 HOURS POST-OP, THE POST-OPERATIVE CT SHOWED EVIDENCE OF COMPRESSION OF THE ILIAC LIMB STENT GRAFT AT THE JUNCTION OF THE AORTIC BODY AND ILIAC LIMB, WITH THROMBOSIS OF THE ILIAC LIMB. A RE-INTERVENTION WAS PERFORMED TO PLACE BALLOON EXPANDABLE STENTS SUCCESSFULLY RESTORING BLOODFLOW. FOLLOWING THE RE-INTERVENTION, THE PATIENT EXPERIENCED PARAPLEGIA. 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 6110677 ↗