Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1410120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M701TVIL1410120J1), received between Oct 12, 2018 and Jan 31, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 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 THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A LEAK IN THE LIMB AREA (CLASSIFIED AS A TYPE IB ENDOLEAK) AS DETECTED BY CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN OVATION IX ILIAC LIMB ON (B)(6) 2020. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: NOTE: THIS PATIENT HAD A PREVIOUS REPORTED EVENT UNDER 3008011247-2018-00081 FOR A TYPE 1A AND 2 ENDOLEAKS THAT WAS TREATED WITH PALMAZ (NON- ENDOLOGIX) BARE METAL STENT AND AN OVATION IX EXTENDER. DURING THE CLINICIAN ASSESSMENT, A PERSISTENT TYPE 1A ENDOLEAK AND TYPE 2 ENDOLEAK (NON - DEVICE FAILURE) FROM THE LUMBAR ARTERY WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant

  MAUDE report 9654119 ↗
• InjuryOct 12, 2018Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE SECONDARY PROCEDURE FOR TREATMENT OF AN ENDOLEAK, THERE WAS AN ISSUE WITH THE RE-LINE AND THE LEFT ILIAC LIMB WAS TRAPPED BY A STRUT AND THE INNER CORE AND NOSECONE WOULD NOT COME OUT THROUGH THE 17FR SHEATH. THE PHYSICIAN PULLED EXTREMELY HARD AND THE NOSECONE DETACHED FROM THE SYSTEM. AFTER SOME MANIPULATING THE PHYSICIAN WAS ABLE TO GET THE SYSTEM OUT. THE SEPARATED NOSECONE WAS RETRIEVED FROM THE PATIENT BODY. ADDITIONALLY, DUE TO THE PHYSICAL RESISTANCE UPON REMOVAL OF THE OVATION IX ILIAC LIMB SYSTEM, THE LEFT ILIAC WAS PERFORATED. THE PERFORATION WAS TREATED WITH PLACEMENT OF A NON-ENDOLOGIX COVERED STENT. AN OVATION IX ILIAC LIMB WAS SUCCESSFULLY DEPLOYED. THE PATIENT WAS STABLE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Perforation

  MAUDE report 7959780 ↗