Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1414160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M701TVIL1414160J1), received between Sep 27, 2016 and Dec 20, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO COIL THE RIGHT INTERNAL ILIAC ARTERY AND PLACE TWO OVATION ILIAC LIMB EXTENSIONS INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT DID WELL AND WAS DISCHARGED HOME.

  Patient problems: Clinical Endoleak

  MAUDE report 18369277 ↗
• InjuryApr 5, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN ALTO STENT GRAFT MAIN BODY AND TWO (2) OVATION IX LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY, FIVE (5) MONTHS POST INITIAL IMPLANT, OCCLUSION WITH LIMB COMPRESSION WAS IDENTIFIED ON THE OVATION IX LEFT LIMB LIKELY DUE TO THROMBOSIS. THE PATIENT HAS DECLINED TREATMENT AND WAS REPORTED AS DOING WELL. THE PATIENT WILL BE MONITORED. ADDITIONAL INFORMATION: SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT IDENTIFIED EVIDENCE OF A TYPE II (NON-DEVICE RELATED) ENDOLEAK FROM INFERIOR MESENTERIC ARTERY.

  Patient problems: Failure of Implant

  MAUDE report 11615964 ↗
• InjuryDec 16, 2020Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE THERE WAS AN OCCLUDED LEFT LIMB AND CROSS LIMBS WERE IDENTIFIED. A SECONDARY PROCEDURE WAS PERFORMED. THE PHYSICIAN PERFORMED AN OPEN THROMBECTOMY THEN PLACED STENTS AND AN OVATION ILIAC LIMB EXTENSION TO COVER THE CLOT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 11024076 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL AORTIC STENT GRAFT SYSTEM. APPROXIMATELY FOUR (4) MONTHS POST-OP, THE PATIENT PRESENTED EMERGENTLY WITH A COMPLAINT OF LEG PAIN. A RIGHT LIMB AND RIGHT FEMORAL OCCLUSION WERE DETECTED WITH POSSIBLE PROXIMAL MIGRATION OF THE LIMB. A DECISION WAS MADE TO TREAT THE PATIENT WITH A 14X100 OVATION IX ILIAC LIMB AND THROMBECTOMY WHICH SUCCESSFULLY RESOLVED THE OCCLUSION. THE PATIENT WAS DISCHARGED POST-OP DAY 2. THE PATIENT IS REPORTED AS DOING WELL AND HEALTHY AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Occlusion; Pain

  MAUDE report 9359178 ↗
• InjuryDec 19, 2018Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY NINE (9) MONTHS POST INITIAL PROCEDURE IN (B)(6) 2018, A LIMB OCCLUSION WAS DETECTED. THE PHYSICIAN PLANS TO RELINE WITH AN OVATION DEVICE AND WILL CONTINUE TO MONITOR THE PATIENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8178626 ↗
• InjuryDec 18, 2017Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY ONE YEAR POST INDEX PROCEDURE WITH AN OCCLUDED RIGHT LIMB. PHYSICIAN HAS ELECTED TO RE-INTERVENE AT A LATER DATE BY PLACING A WIRE INTO THE LIMB AND BALLOONING/STENTING AS NECESSARY TO RESTORE FLOW TO THE LIMB. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7125697 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AFX STENT GRAFT SYSTEM WITH OVATION IX ILIAC LIMBS WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IIIA ENDOLEAK AT THE OVERLAP OF THE AFX MAIN BODY AND THE OVATION IX ILIAC LIMB STENT GRAFT. A RE-INTERVENTION WAS PERFORMED TO PLACE A BALLOON EXPANDABLE STENT AND AN ADDITIONAL AFX STENT GRAFT TO RE-LINE THE STENT GRAFT SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5980708 ↗