Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1412100-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M701TVIL1412100J1), received between Feb 27, 2018 and Aug 28, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Device Stenosis; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. ON (B)(6) 2019 THE PATIENT DEVELOPED AN OCCLUDED RIGHT LIMB WITH THROMBUS IN THE RIGHT COMMON FEMORAL ARTERY ANEURYSM. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY OF THE RIGHT INTERNAL ILIAC ARTERY AS WELL AS IMPLANT UNKNOWN (NON-ENDOLOGIX) BILATERAL COMMON ILIAC ARTERY STENTS. THEN A RIGHT EXTERNAL ILIAC ARTERY/SUPERFICIAL FEMORAL ARTERY EMBOLECTOMY WAS PERFORMED, AN OPEN THROMBECTOMY OF THE RIGHT CORONARY FEMORAL ARTERY WAS PERFORMED, AND A VIABAHN (NON-ENDOLOGIX) STENT WAS PLACED FROM THE RIGHT SUPERFICIAL FEMORAL ARTERY TO BELOW-KNEE POPLITEAL ARTERY. THE FINAL PATIENT'S STATUS WAS REPORTED AS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22913272 ↗
• InjuryOct 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THE GRAFT WAS DIFFICULT TO DEMATE, THE IMPLANT WAS DISPLACED AND THERE WAS TYPE 1A ENDOLEAK. THIS EVENT WAS PREVIOUSLY CAPTURED PER PATIENT ID (B)(6). PATIENT WAS NOT IN ROUTINE FOLLOW-UP CARE. APPROXIMATELY SIX (6) YEARS POST IMPLANT THE PHYSICIAN REPORTED THAT THE AAA RUPTURED FROM A TYPE 1 ENDOLEAK. UPON FURTHER REVIEW IT APPEARS THERE WAS A JUXTARENAL ANEURYSM THAT MAY HAVE CAUSED THE RUPTURE AS THERE WAS NO VISIBLE TYPE 1A ENDOLEAK, AND THE ISSUE APPEARS TO BE WHERE THAT PROXIMAL CROWN IS ABOVE THE OVATION IX FABRIC. THE PHYSICIAN ELECTED TO IMPLANT A COOK PMEG (PHYSICIAN MODIFIED ENDOGRAFT) (NON-ENDOLOGIX) STENT TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST THIS SECONDARY PROCEDURE ON (B)(6) 2022. THIS EVENT WAS PREVIOUSLY CAPTURED PER PATIENT ID (B)(6). ADDITIONALLY, DURING THE INITIAL IMPLANT PROCEDURE, A LACERATION OCCURRED THAT REQUIRED EMERGENT REPAIR. IN ADDITION, PATIENT RETURNED TO THE HOSPITAL TWELVE (12) DAYS POST INITIAL PROCEDURE FOR BLOOD TRANSFUSION AND LEFT GROIN HEMATOMA EV

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 15570932 ↗
• InjurySep 20, 2021Complete Blockage; Device-Device Incompatibility; Complete Blockage; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL EXTENSION AND AN OVATION LIMB EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY ONE (1) DAY POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS OF THE RIGHT LIMB CAUSING AN OCCLUSION OF THE STENT GRAFT. THE PHYSICIAN SUCCESSFULLY TREATED THE PATIENT BY IMPLANTING TWO (2) BARE METAL PERIPHERAL STENTS (NON-ENDOLOGIX) AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12502486 ↗
• InjuryFeb 27, 2018Difficult to Advance; Difficult to Advance

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE IPSILATERAL LIMB WAS UNABLE TO BE ADVANCED, DESPITE TROUBLESHOOTING TECHNIQUES. PHYSICIAN ELECTED TO REMOVE THE DEVICE AND USE A NEW DEVICE. THE LIMB WAS SUCCESSFULLY IMPLANTED AND THE CASE CONCLUDED WITH SUCCESSFUL ANEURYSM EXCLUSION. THERE WAS NO PATIENT SEQUELAE AS RESULT OF THIS EVENT, AND AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299390 ↗