Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1412120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M701TVIL1412120J1), received between Dec 31, 2016 and May 3, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE THERE WAS ANEURYSM ENLARGEMENT. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED AND THERE WAS A MINOR TYPE 1B ENDOLEAK COMING FROM THE RIGHT ILIAC ARTERY. THE PHYSICIAN COULD NOT SEE ANY OTHER ISSUES FOR THE SAC ENLARGEMENT. THE PHYSICIAN DECIDED TO COIL THE RIGHT HYPOGASTRIC ARTERY AND EXTEND THE ILIAC LIMB WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB INTO THE EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED AS FINE POST-SECONDARY PROCEDURE AND WAS DISCHARGED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19241980 ↗
• InjuryOct 21, 2021Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT GRAFT SYSTEM. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE LIMB OCCLUSION WAS IDENTIFIED. REINTERVENTION WAS COMPLETED BY DECLOTTING THE LIMB AND IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB. THERE WAS ALSO PROXIMAL STENOSIS THAT WAS BALLOONED USING A 10 X 4 PTA BALLOON. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant; Obstruction/Occlusion

  MAUDE report 12674762 ↗
• InjuryAug 24, 2021Complete Blockage; Collapse; Patient-Device Incompatibility; Complete Blockage; Collapse; Patient-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) WEEKS POST INITIAL IMPLANT THERE WAS A LIMB OCCLUSION OF THE GRAFT NOTED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) 13X10 GORE VIABAHN (NON-ENDOLOGIX) STENTS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12361385 ↗
• InjuryFeb 14, 2019Adverse 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. APPROXIMATELY 18 (EIGHTEEN) MONTHS LATER, LEFT LIMB THROMBOSIS WAS DETECTED. SUCCESSFUL RE-INTERVENTION WAS PERFORMED WITH OPEN THROMBECTOMY OF THE LIMB WITH PATCH ANGIOPLASTY OF THE RIGHT COMMON FEMORAL ARTERY. IN ADDITION BILATERAL 9X38 NON-ENDOLOGIX PTFE COVERED BALLOON EXPANDABLE STENTS WERE IMPLANTED TO EXTENDED THE LIMBS PROXIMALLY.

  Patient problems: Occlusion

  MAUDE report 8341739 ↗
• InjuryJun 8, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIAL IMPLANTED ON (B)(6) 2018 WITH AN OVATION TO TREAT AN AORTIC ANEURYSM. ENDOLOGIX WAS MADE AWARE OF A PATIENT THAT WENT INTO THE HOSPITAL FOR REPORTED COLD LEGS (ISCHEMIA). UPON REVIEW OF THE CT SCAN, PHYSICIAN NOTED THE DEVICE LIMBS WERE PLACED ON THE IPSILATERAL GATE AND OBSERVED A TYPE 3 ENDOLEAK. A RE-INTERVENTION WAS PERFORMED WITH A NON-ENDOLOGIX DEVICE ON (B)(6) 2018 TO RESOLVE THE LEAK. PATIENT WAS IN GOOD CONDITION POST SECONDARY.

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 7585134 ↗
• 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 1 MONTH FOLLOW-UP IMAGING SHOWED THE PRESENCE OF NARROWING WITHIN THE ILIAC ARTERIES. THE PATIENT UNDERWENT A PROPHYLACTIC 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: Stenosis

  MAUDE report 6216747 ↗