Ovation iX Iliac Stent Graft Iliac Extension (REF TV-EX222245-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M701TVEX222245J1), received between Aug 21, 2018 and Apr 8, 2024 — classified as 5 injuries.

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

• InjuryApr 8, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO AND HALF (2.5) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP, A TYPE 1B ENDOLEAK WAS SUSPECTED BUT CONFIRMED TO BE A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT NON-ENDOLOGIX COILS AND AN OVATION IX ILIAC LIMB TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19058225 ↗
• InjuryOct 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (OFF -LABEL DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU). APPROXIMATELY 3 YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK AND ANEURYSM ENLARGEMENT (RIGHT ILIAC) WAS IDENTIFIED. THE PATIENT IS PENDING RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15673217 ↗
• InjuryMay 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, STENT STENOSIS WITH 50-74 % OF THE RIGHT EXTERNAL ILIAC ARTERY IN THE OVATION LIMB WAS IDENTIFIED. NO INTERVENTION WAS REPORTED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 11791203 ↗
• InjuryApr 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION, AND TWO (2) OVATION IX LIMB EXTENDERS (STENT GRAFTS) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. IT WAS REPORTED THAT THE TWO (2) OVATION IX LIMB EXTENDERS WERE IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (LCIA) AND THAT THE PATIENT HAD AN INFECTION IN THE LCIA PRIOR TO IMPLANTING THESE STENT GRAFTS. NOW, APPROXIMATELY 46 DAYS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED IN THE LCIA. IT WAS REPORTED THAT THE PATIENT STILL HAS AN INFECTION IN THE LCIA THAT IS MOST LIKELY CAUSING THIS AREA NOT TO SEAL. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT THREE (3) MORE STENT GRAFTS IN THE LCIA: TWO (2) AFX LIMB STENT GRAFTS AND ONE (1) OVATION IX EXTENDER TO RESOLVE THIS ENDOLEAK. THE PATIENT WAS REPORTED STILL IN THE HOSPITAL FOR TREATMENT OF THE INFECTION.

  Patient problems: Aneurysm; Failure of Implant; Unspecified Infection

  MAUDE report 11659198 ↗
• InjuryAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED WITH AFX2 FOR AORTO-ILIAC OCCLUSIVE DISEASE (AIOD) WHICH IS CURRENTLY OUTSIDE THE INDICATIONS FOR USE. THE AFX 2 BIFURCATED WAS PLACED WITHOUT ISSUE. THE PHYSICIAN PROCEEDED TO PLACE AN OVATION IX EXTENDER AS A INFRARENAL CUFF, UPON REMOVAL OF THE OVATION DELIVERY SYSTEM IT WAS NOTED THAT THE EXTENSION WAS DISLODGED AND COVERING THE LEFT RENAL. THE PHYSICIAN ATTEMPTED TO PULL DOWN THE EXTENSION WITH BOTH A RELIANT AND POWERFLEX BALLOON, BUT IT WAS UNSUCCESSFUL. ANOTHER UNSUCCESSFUL ATTEMPT WAS PERFORMED WITH A DESTINO TUNNEL. THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR AND PERFORM A LEFT EXTERNAL ILIAC BYPASS WITH A NON ENDOLOGIX STENT, AND ANOTHER TWO (2) NON ENDOLOGIX STENT WAS PLACED IN THE PROXIMAL COMMON ILIAC DOWN TO THE HYPOGASTRIC. A FINAL ANGIO WAS COMPLETED SHOWING ALL VESSEL PATENT. A LEFT RENAL BYPASS WAS COMPLETED TO RESTORE THE RENAL FLOWS. PATIENT WAS REPORTED TO TOLERATE THE PROCEDURE WELL. NO ADDITIONAL PATIENT SEQUALAE HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801085 ↗