Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1418160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M701TVIL1418160J1), received between Jan 2, 2019 and May 9, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryMay 9, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. ON APRIL 18, 2024, IT WAS REPORTED THAT A POSSIBLE TYPE 1B ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION, DURING WHICH THE PHYSICIAN ELECTED TO IMPLANT TWO (2) OVATION IX ILIAC LIMBS, WITH ONE OF THE LIMBS BEING EXTENDED DOWN INTO THE RIGHT EXTERNAL ILIAC ARTERY.

  Patient problems: Clinical Endoleak

  MAUDE report 19280488 ↗
• InjuryJun 2, 2021Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A ALTO MAIN BODY AND TWO (2) ILIAC LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). NOW APPROXIMATELY ONE MONTH POST INITIAL PROCEDURE DURING A FOLLOW UP VISIT THE PATIENT WAS IDENTIFIED WITH A OCCLUDED RIGHT ILIAC LIMB. THE PHYSICIAN ELECTED TO RESOLVE THE OCCLUSION WITH A THROMBECTOMY BALLOON AND PLACE FOUR ILIAC LIMBS. PATIENT IS CURRENTLY BEING MONITORED AND DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 11925291 ↗
• InjuryNov 24, 2020Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM AND TWO (2) OVATION IX ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE A TYPE 1B ENDOLEAK WAS IDENTIFIED DURING A SCAN. THE PATIENT WAS REPORTED TO BE STABLE. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN ADDITIONAL OVATION IX ILIAC LIMB. REPORTEDLY THE PROCEDURE WENT WELL. THE FINAL PATIENT STATUS WAS REPORTED TO BE GOOD.

  Patient problems: Failure of Implant

  MAUDE report 10889927 ↗
• InjuryAug 18, 2020Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 YEAR POST PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A COLD LEG. PHYSICIAN ELECTED TO ADMINISTER A LYTIC AND PERFORM AN ANGIO-JET. PHYSICIAN NOTICED THE LEFT ILIAC LIMB WAS HIGHER THAN THE RIGHT AND PHYSICIAN THOUGHT IT WAS IMPEDING FLOW INTO THAT LIMB. PHYSICIAN ELECTED TO EXTEND THE LIMB TO MATCH THE OTHER SIDE AND PUT A SECOND STENT TO TRAP ANY ADDITIONAL THROMBUS LEFT. FINAL ANGIO LOOKED GREAT AND PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION: DURING CLINICAL ASSESSMENT, OCCLUSION OF THE LEFT LIMB WAS ALSO IDENTIFIED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Failure of Implant; Occlusion; Thrombosis; Thrombus

  MAUDE report 10423685 ↗
• InjuryApr 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK ON THE LEFT SIDE WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT IS CURRENTLY BEING MONITORED WHILE AWAITING AN INTERVENTION. ADDITIONAL INFORMATION: RE-INTERVENTION COMPLETED ON (B)(6) 2020. THE PHYSICIAN ELECT TO IMPLANT AN OVATION IX ILIAC LIMB TO TREAT THIS EVENT. THE PATIENTS STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10003068 ↗
• InjuryApr 30, 2019Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, DURING COILING OF A TYPE 2 ENDOLEAK WITH SAC GROWTH (NON-DEVICE RELATED FAILURE) A POSSIBLE TYPE 3B ENDOLEAK OF THE LEFT LIMB WAS IDENTIFIED. AN ANGIOGRAM WAS PERFORMED; HOWEVER, INCONCLUSIVE. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL LIMB WITH ANOTHER OVATION IX LIMB. THE SUBSEQUENT ANGIOGRAM SHOWED CONCLUSIVELY THAT THE POSSIBLE TYPE 3B ENDOLEAK WAS RESOLVED. REPORTEDLY, THE PATIENT WAS FANTASTIC POST RE-INTERVENTION AND WAS TO BE DISCHARGED THE MORNING AFTER.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8567039 ↗
• InjuryJan 2, 2019Complete Blockage; Improper or Incorrect Procedure or Method; Malposition of Device; Complete Blockage; Improper or Incorrect Procedure or Method; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED WITH OVATION IX TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED APPROXIMATELY 1-MONTH POST-OP WITH LEFT LEG CLAUDICATION. A CTA SCAN REVEALED A TOTAL OCCLUSION OF THE LEFT ILIAC LIMB STENT GRAFT. THE PHYSICIAN IS PLANNING TO TREAT THE PATIENT BY FEM-FEM BYPASS- RIGHT COMMON FEM TO LEFT COMMON FEM. THE TREATMENT HAS NOT YET BEEN SCHEDULED. THE CURRENT PATIENT CONDITION WAS NOT INITIALLY REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8210923 ↗