Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1410100-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M701TVIL1410100J1), received between Dec 31, 2016 and Mar 21, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020, WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED ON FEBRUARY 20, 2024, THAT DURING A ROUTINE FOLLOW-UP, A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC LIMB WAS IDENTIFIED. THE PATIENT'S STATUS IS CURRENTLY GOOD PENDING A RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 18955752 ↗
• InjuryMar 21, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020, WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED ON FEBRUARY 20, 2024, THAT DURING A ROUTINE FOLLOW-UP, A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC LIMB WAS IDENTIFIED. THE PATIENT'S STATUS IS CURRENTLY GOOD PENDING A RE-INTERVENTION. ADDITIONAL INFORMATION: THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE INVOLVING THE IMPLANTATION OF A GORE VBX STENT GRAFT (NON-ENDOLOGIX). THE PRECISE DATE OF THIS REINTERVENTION REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 18952428 ↗
• InjuryMay 22, 2021Complete Blockage; Device-Device Incompatibility; Insufficient Device Problem Information; Complete Blockage; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT WHILE THE PATIENT WAS IN RECOVERY THE PATIENTS LEFT LIMB AND EXTERNAL ILIAC IMMEDIATELY OCCLUDED AND THE PHYSICIAN HAD TO PERFORM A FEM FEM BYPASS. PATIENT WAS DISCHARGED ON AN UNKNOWN DATE. NOW, THE PATIENT HAS PRESENTED WITH SEVERE GROIN INFECTION FROM THE FEM FEM BYPASS AND POSSIBLE MULTIPLE TYPE II ENDOLEAKS. PATIENT IS IN CRITICAL CONDITION RECOVERING FROM THE INFECTION AND RE-INTERVENTION IS BEING DISCUSSED, BUT NOT YET SCHEDULED. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING THAT NON-DEVICE-RELATED LEFT FOOT ISCHEMIA (DUE TO INFECTED FEMORAL-FEMORAL BYPASS GRAFT) AND A TYPE IA ENDOLEAK ALSO OCCURRED AT THE TIME OF THE REPORTED EVENT. NOTE: THE TYPE IA ENDOLEAK SELF-RESOLVED WITHIN 30 DAYS (NO TREATMENT WAS REQUIRED).

  Patient problems: Failure of Implant

  MAUDE report 11868134 ↗
• InjuryMar 17, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN AND LIMB THROMBOSIS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PERFORMING BILATERAL ENDARTERECTOMIES, AND IMPLANTING BILATERAL SELF-EXPANDING STENTS IN THE COMMON AND EXTERNAL ILIACS. THE PHYSICIAN ALSO IMPLANTED A 10MM ATRIUM (NON-ENDOLOGIX) STENT IN THE SEALING RINGS IN RESPONSE TO AN ABNORMALLY SMALL AORTIC FLOW LUMEN (APPROXIMATELY 9MM). AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Pain; Thrombosis

  MAUDE report 9845388 ↗
• InjuryDec 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 10 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF AN OCCLUSION OF THE RIGHT ILIAC LIMB STENT GRAFT AND THROMBUS IN THE LEFT ILIAC LIMB STENT GRAFT IN THE PRESENCE OF ANATOMICAL NARROWING. THE PATIENT UNDERWENT A RE-INTERVENTION TO PLACE TWO BALLOON EXPANDABLE STENTS BILATERALLY TO MAINTAIN LUMENAL PATENCY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion; Stenosis

  MAUDE report 6216746 ↗