Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1428160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M701TVIL1428160J1), received between Jun 14, 2018 and Jul 27, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Separation Problem; Separation Problem

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). ). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A TYPE 3A ENDOLEAK WHERE THE LEFT LIMB WAS FOUND TO HAVE SEPARATED FROM THE MAIN BODY AND OCCLUDED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER ALTO STENT GRAFT SYSTEM TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT DID WELL AND WAS DISCHARGED THE FOLLOWING DAY. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST TYPE 2 ENDOLEAK (NON-DEVICE RELATED) OF THE LUMBAR ARTERY OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 2 ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE OPERATIVE REPORT DATED 07/25/2023.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 17410530 ↗
• InjuryAug 21, 2021Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE ILIAC LIMB STENT GRAFT HAS MIGRATED UPWARDS. THE RIGHT COMMON ILIAC ARTERY HAS A 9CM ANEURYSM RESULTING IN A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO COIL THE HYPOGASTRIC ARTERY TO EXCLUDE IT AND IMPLANTED TWO (2) ILIAC LIMBS IN THE EXTERNAL ILIAC ARTERY TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING GOOD POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12351919 ↗
• InjuryAug 11, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; 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 2.5 WEEKS POST INITIAL PROCEDURE, THE PATIENT WAS TREATED FOR AN OCCLUDED LEFT LIMB. THE PHYSICIAN RELINED AND EXTENDED THE ORIGINAL OVATION IX ILIAC LIMB WITH AN ADDITIONAL OVATION IX ILIAC LIMB. INTERVENTION WAS SUCCESSFUL AND PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 10393907 ↗
• InjuryMar 17, 2020Use of Device Problem; Migration; Use of Device Problem; Migration

  THE PATIENT WAS INITIALLY TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT; THIS INITIAL PROCEDURE IS OFF-LABEL DUE TO EMERGENT USE OF AN OVATION DEVICE. APPROXIMATELY TEN (10) DAYS POST INITIAL IMPLANT PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. THE CT (COMPUTED TOMOGRAPHY) SCAN DETECTED A TYPE IA AND IB ENDOLEAKS WITH MIGRATION (UNKNOWN DISTANCE) OF THE LEFT LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB DEVICE AND A PALMAZ STENT ON (B)(6) 2020. THE TYPE IB AND IA ENDOLEAKS WERE CONFIRMED RESOLVED. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT), AND IS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Pain

  MAUDE report 9845124 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) MONTH POST-OP, THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP AND A TYPE IB ENDOLEAKS WAS DETECTED. THE PHYSICIAN IS PLANNING TO TREAT THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 9187715 ↗
• InjuryOct 17, 2018Leak/Splash; Unintended Movement; Leak/Splash; Unintended Movement

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE INDEX PROCEDURE WAS SEMI-EMERGENT AS THE PATIENT WAS SEEN BY A DOCTOR FOR OTHER REASONS WHEN AN 8CM AAA WAS DISCOVERED WITH BILATERAL COMMON ILIAC ECTASIA, AND A HIGH DEGREE OF ILIAC TORTUOSITY ON THE LEFT SIDE. THE PATIENT WAS ORIGINALLY TREATED WITH BILATERAL OVATION 28MM ILIAC LIMBS, KNOWING THAT THE LEFT LIMB MAY NOT HAVE LONG-TERM SEAL. THE PATIENT RETURNED FOR THE TWO (2) MONTH ROUTINE FOLLOW-UP PRESENTING WITH A TYPE IB ENDOLEAK. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2018; HOWEVER, THE TYPE IB ENDOLEAK WAS NOT SEALED. THE NEW LIMB WAS NOT ABLE TO TRACK AND WAS NOT DEPLOYED. THE ORIGINAL LIMB HAD ALREADY PULLED OUT OF THE ILIAC PRIOR TO THE SECONDARY ATTEMPT. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE CASE. ON (B)(6) 2018, THE PATIENT WAS TREATED WITH IMPLANT OF TWO OVATION IX ILIAC LIMBS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7974783 ↗
• InjuryOct 3, 2018Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX STENT GRAFT SYSTEM FOR AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY FOUR (4) MONTHS POST-OP THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP WITH POSSIBLE RIGHT LEG CLAUDICATION. AN ANGIOGRAM WAS COMPLETED REVEALING A POPLITEAL ARTERY ANEURYSM WITH LIMITED FLOW IN THE RIGHT LEG AND THE RIGHT ILIAC LIMB POSITIONED LOWER THAN THE LEFT. IN ADDITION THE RIGHT ILIAC LIMB APPEARED TO BE PINCHED PROXIMALLY. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH NON-ENDOLOGIX PRODUCTS; SELF EXPANDING STENT IMPLANTED INTO THE RIGHT ILIAC LIMB WHICH PROVIDED ADEQUATE FLOW. FURTHERMORE, THE PATIENT WILL UNDERGO AN ADDITIONAL TREATMENT FOR THE UNRELATED POPLITEAL ARTERY ANEURYSM ON A LATER DATE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Claudication; Stenosis

  MAUDE report 7930082 ↗
• InjurySep 25, 2018Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THIS WAS AN OFF LABEL CASE. THE PATIENT WAS ADMITTED TO THE ER WITH ABDOMINAL AND BACK PAIN. COMPUTERIZED TOMOGRAPHY REVEALED A TYPE 1B ENDOLEAK OF THE PATIENTS LEFT ILIAC LIMB. AT THE TIME OF THE INDEX PROCEDURE, THE PHYSICIAN WAS AWARE THAT THE LIMB IN THIS ILIAC WAS UNLIKELY PROVIDE A LONG-TERM SEAL BUT HAD EMBOLIZED THE CONTRALATERAL HYPOGASTRIC AND DIDN'T WANT TO EMBOLIZE BOTH HYPOGASTRICS. ON (B)(6) 2018, TWO ADDITIONAL OVATION IX ILIAC LIMBS WERE IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 7907153 ↗
• InjuryAug 17, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  THE PATIENT WAS INITIALLY TREATED WITH OVATION IX. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE A TYPE IB ENDOLEAK WAS DETECTED. ON (B)(6) 2018, THE PHYSICIAN ELECTED COILED THE INTERNAL ILIAC AND EXTENDED INTO THE EXTERNAL WITH AN OVATION LIMB TO SUCCESSFULLY RESOLVE THE ENDOLEAK. AS OF THIS REPORT, NO ADDITIONAL PATIENT SEQUELAE HAVE BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7793114 ↗
• InjuryJun 14, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2014. ON (B)(6) 2018, PATIENT WAS BROUGHT IN AND A GRAFT WAS PLACED FIX AND ENDOLEAK TYPE IIIB CAPTURED IN A SEPARATE REPORT. THE PATIENT LEFT THE ROOM WITH LEAK FIXED AND GOOD FLOW. APPROXIMATELY TWO (2) HOURS LATER, THE PATIENT EXPERIENCED A COLD LEFT LEG. HE WAS TAKEN BACK TO CATHLAB AND ANGIO JET WAS USED TO UNCLOT THE LEFT LIMB. THE PATIENT AGAIN EXPERIENCED COLDNESS IN THE LEFT LEG, THE PHYSICIAN ELECTED TO PERFORM A FEM/FEM. THE PATIENT IS REPORTED TO BE DOING WELL AND WALKING.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7604266 ↗