Ovation iX Iliac Stent Graft Iliac Extension (REF TV-EX282845-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVEX282845J1), received between Dec 14, 2017 and Feb 20, 2026 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Off-Label Use” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Off-Label Use; Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, AND TWO OVATION IX EXTENDERS ON (B)(6) 2019. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THERE WAS SEPARATION OF THE OVATION IX LIMB FROM THE LEFT ILIAC CAUSING A TYPE IB ENDOLEAK. ON (B)(6) 2026 THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB TO BRIDGE THE LEFT COMMON ILIAC SEPARATION BETWEEN THE EXISTING OVATION IX ILIAC LIMB AND AFX2 BSG DEVICE LIMB. THEN A NEW AFX2 BSG WAS IMPLANTED TO HELP BRIDGE AND SEAL THE ILIAC TOGETHER. THEN AN OVATION IX EXTENDER WAS PLACED ON THE RIGHT ILIAC. THE ENDOLEAK WAS RESOLVED, THE PATIENT WAS STABLE AND LEFT THE HOSPITAL THE NEXT DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 24402178 ↗
• InjuryDec 9, 2025Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER ON (B)(6) 2018. ON (B)(6) 2025, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK FROM THE RIGHT ILIAC WAS FOUND. ON (B)(6) 2025 AN INTERVENTION OCCURRED WITH IMPLANTATION OF AN AFX2 BSG, A VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB. THE LEAK WAS RESOLVED AND THE PATIENT IS DOING GREAT. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Clinical Endoleak

  MAUDE report 23761187 ↗
• InjuryOct 26, 2022Material Puncture/Hole; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL EXTENSION AND (2) OVATION IX EXTENDERS (OFF-LABEL). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, PATIENT HAS BEEN IDENTIFIED WITH A 1B ENDOLEAK AND IS PENDING RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15673250 ↗
• InjuryMar 16, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM (1 ALTO MAIN BODY, 4 OVATION IX ILIAC LIMBS AND 1 OVATION IX EXTENDER). AN INTEROPERATIVE TYPE 1B ENDOLEAK REMAINED AFTER THE INITIAL PROCEDURE AND THE PHYSICIAN HAS ELECTED TO MONITOR THE PATIENT. PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Failure of Implant

  MAUDE report 13777625 ↗
• InjuryJun 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AORTIC EXTENSION AND TWO (2) OVATION IX EXTENDERS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED FOR ANOTHER MEDICAL ISSUE AND IDENTIFIED A TYPE 1B ENDOLEAK FROM THE PATIENT'S RIGHT ILIAC AND A TYPE 2 ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY (IMA). THE PHYSICIAN ELECTED TO COIL THE IMA, COVERED THE RIGHT HYPOGASTRIC ARTERY AND EXTENDED INTO THE EXTERNAL ILIAC ARTERY WITH AN OVATION IX ILIAC LIMB TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS FINE POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12089508 ↗
• InjuryMay 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX MAIN BODY AND (4) ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (8) EIGHT MONTHS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH AN ENDOLEAK TYPE 1B WHICH WAS DISCOVERED DURING ROUTINE COMPUTED TOMOGRAPHY (CT) SCAN. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT (2) TWO ILIAC LIMBS AND THE LEFT HYPOGASTRIC ARTERY WAS COILED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 11868222 ↗
• DeathJul 5, 2018Partial Blockage; Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem; Partial Blockage; Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem

  ENDOLOGIX BECAME AWARE OF A NARROWING AT DISTAL RIGHT COMMON ILIAC ON (B)(6) 2018 AS REPORTED BY PHYSICIAN (B)(6) AT (B)(6) . THE REPORTED STENOSIS WAS DISCOVERED DURING A FOLLOW-UP ULTRASOUND ON AN UNKNOWN DATE. PHYSICIAN STATES THE STENOSIS IS AT THE END OF THE STENT GRAFT WHICH WAS LANDED RIGHT AT THE HYPOGASTRIC TAKE OFF. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, ONE (1) AFX VELA INFRARENAL, THREE (3) VELA SUPRARENALS, AND FOUR (4) OVATION IX EXTENDERS ON (B)(6) 2018 BY THE REPORTING PHYSICIAN. THE PATIENT IS IN STABLE CONDITION. PHYSICIAN DECIDED TO NOT DO A RE-INTERVENTION, AND WILL ONLY ANTICOAGULATE THE PATIENT AND MONITOR.

  Patient problems: Death; Rupture; Stenosis

  MAUDE report 7663638 ↗
• InjuryDec 14, 2017Hole In Material; Leak/Splash; Off-Label Use; Hole In Material; Leak/Splash; Off-Label Use

  AN AFX BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB STENT GRAFT WERE IMPLANTED TO REPAIR A PREVIOUSLY PLACED AFX BIFURCATED STENT GRAFT AND SUPRARENAL AORTIC EXTENSION. APPROXIMATELY 1 MONTH AFTER THE RE-INTERVENTION, THE PATIENT RETURNED WITH BACK PAIN. THE PATIENT WAS DIAGNOSED WITH A TYPE IIIB ENDOLEAK OF THE OVATION LIMB. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A GORE DEVICE, SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7117223 ↗