Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1416120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M701TVIL1416120J1), received between May 17, 2017 and Apr 3, 2023 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2023Device Stenosis; Device Stenosis

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY (4) FOUR YEARS POST-IMPLANT RIGHT LIMB THROMBOSIS WAS IDENTIFIED. REINTERVENTION IS PLANNED FOR AN OPEN THROMBECTOMY WITH RELINING OF THE LIMB AND STENTING OF THE PROXIMAL EXTERNAL ILIAC ARTERY, BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16665569 ↗
• InjurySep 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A NON-AAA-RELATED CAUSE, AND SCAN IMAGING REVEALED A TYPE IB ENDOLEAK OF THE LEFT ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS IN BOTH ILIAC ARTERIES ON (B)(6) 2022. THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15452244 ↗
• InjuryFeb 9, 2021Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, AN OVATION IX LIMB EXTENSION AND AN OVATION IX LIMB EXTENDER 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 AFX2 SYSTEM PER THE IFU. APPROXIMATELY 1.5 YEAR POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED DURING THE CLINICAL ASSESSMENT OF A PREVIOUS CASE REPORTED (2031527-2020-00368). THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, VELA (AFX) INFRARENAL STENT GRAFT AND A VELA (AFX) SUPRARENAL STENT GRAFT TO RESOLVE THE REPORTED TYPE 1B ENDOLEAK. THE PATIENT WAS REPORTED AS STABLE POST RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 11305049 ↗
• DeathJan 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM AND TWO EXTENDERS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE THE PATIENT PRESENTED SYMPTOMATIC TO THE EMERGENCY ROOM AND WITH WHAT APPEARS TO BE A JUNCTION LEAK (CLASSIFIED AS A TYPE IIIA ENDOLEAK) FROM THE 16X120 AND 16X45 LIMBS ON THE PATIENT'S RIGHT SIDE. THE PHYSICIAN REPAIRED THE ENDOLEAK WITH ANOTHER MANUFACTURER'S STENT GRAFTS ON (B)(6) 2020 AND THE ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 11139564 ↗
• InjuryAug 26, 2019Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  THE PATIENT WAS INITIALLY TREATED EMERGENTLY WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM OUTSIDE THE INDICATIONS FOR USE. APPROXIMATELY 1-YEAR POST OP A COMPUTED TOMOGRAPHY REVEALED A LEFT TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A 22X160 OVATION ILIAC LIMB SUCCESSFULLY RESOLVING THE REPORTED ENDOLEAK. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST LEFT OVATION LIMB STENT MIGRATION (PROXIMAL) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 8933022 ↗
• InjuryApr 23, 2019Unintended Movement; Unintended Movement

  AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, TWO (2) AFX LIMB STENT GRAFTS, AND AN OVATION IX ILIAC LIMB WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IN ADDITION, THE RIGHT HYPOGASTRIC ARTERY WAS COILED. APPROXIMATELY THREE (3) YEARS POST OP, A ROUTINE FOLLOW-UP CT IDENTIFIED AN ILIAC AAA (UNKNOWN DIAMETER) ON THE RIGHT SIDE AND THE OVATION IX ILIAC LIMB HAS MOVED UP INTO THE ILIAC AAA. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN OVATION ILIAC LIMB.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8542400 ↗
• InjuryAug 22, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED THE OVATION SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(4) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 1B ENDOLEAK. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL LLIAC LIMB. THE ENDOLEAK WAS RESOLVED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7806164 ↗
• InjuryJun 14, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, THE OVATION ENDOVASCULAR SEALING SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE A INDETERMINATE ENDOLEAK (POSSIBLE TYPE 2 OR 3A) WITH NO SAC GROWTH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7603970 ↗
• InjuryFeb 7, 2018Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ILIAC LIMB STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PATIENT RETURNED FOR UNKNOWN REASON WHERE PHYSICIAN OBSERVED THROMBOSIS OF THE RIGHT LIMB. THE RIGHT LIMB WAS REPORTED TO HAVE COLLAPSED IN THE LEG OF THE MAIN BODY. THE PHYSICIAN ELECTED TO RE-INTERVENE BY EXPLANTING THE DEVICE, SUCCESSFULLY RESOLVING THE THROMBOSIS. THE PATIENT IS REPORTED TO BE DOING WELL POST-PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Blood Loss; Claudication; Ischemia; Occlusion; Pain; Thrombosis

  MAUDE report 7250080 ↗
• InjuryMay 17, 2017Occlusion Within Device; Off-Label Use; Occlusion Within Device; Off-Label Use

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PATIENT RETURNED EMERGENTLY WITH DIMINISHED PULSE IN THE RIGHT GROIN. PHYSICIAN ELECTED TO DO AN OPEN THROMBECTOMY OF THE RIGHT ILIAC. THE RIGHT LIMB WAS RELINED USING A 14X14X160 LIMB THAT EXTENDED DOWN INTO THE EXTERNAL ILIAC. UPON COMPLETION OF THE PROCEDURE, THE PHYSICIAN NOTED THAT THE RIGHT LIMB DID NOT FILL AS QUICKLY AS THE LEFT LIMB AND ELECTED TO EXTEND BOTH LIMBS INTO THE AORTIC BODY (KISSING LIMBS). THE PROCEDURE CONCLUDED WITHOUT ISSUES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Intimal Dissection; Ischemia; Occlusion; Thrombus

  MAUDE report 6572124 ↗