Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1414100-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1414100J1), received between Jul 9, 2016 and Feb 15, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (3 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 15, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX ILIAC LIMB. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE A TYPE II ENDOLEAK AND A TYPE IB ENDOLEAK WERE IDENTIFIED WITH NO ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. (REPORTED UNDER MFR# 3008011247-2018-00066). NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE THE TYPE II ENDOLEAK AND A TYPE IB ENDOLEAK ARE PERSISTENT. REINTERVENTION HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 13537757 ↗
• InjuryDec 29, 2021Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. EIGHTEEN (18) DAYS POST INITIAL PROCEDURE, A TYPE IB ENDOLEAK AND A TYPE II ENDOLEAK (NON-DEVICE RELATED) WERE IDENTIFIED. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN ADDITIONAL OVATION IX ILIAC LIMB ON EACH SIDE. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13113206 ↗
• InjuryJan 6, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A BUNCHED AND THROMBOSED LEFT PROXIMAL ILIAC LIMB. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN PLANS TO RE-INTERVENE AND WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion; Stenosis; Thrombosis

  MAUDE report 9555476 ↗
• InjuryJul 24, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY SEVEN (7) WEEKS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN OCCLUDED PROXIMAL RIGHT-SIDE LIMB (LIMBS CROSSED AT BIFURCATION) AND LEG PAIN; THE CROSSED LIMBS IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE JUXTA-RENAL ANGULATION). THE CTA (COMPUTED TOPOGRAPHY ANGIOGRAPHY) CONFIRMED THE OCCLUSIVE FLOW WITH THROMBUS IN THE MAIN BODY AND A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A PALMAZ (NON-ENDOLOGIX) STENT AT THE PROXIMAL PORTION OF THE PREVIOUSLY PLACED OVATION IX MAIN BODY, AND TWO (2) GORE (NON-ENDOLOGIX) VBX 8X29 COVERED STENTS AT THE PROXIMAL MAIN BODY-LIMBS JUNCTION TO THE DISTAL EDGE OF THE PALMAZ STENTS ON AN UNKNOWN DATE. THE TYPE IA ENDOLEAK WAS CONFIRMED RESOLVED AND THE FLOW IN THE RIGHT-SIDE RESTORED. THE PATIENT IS REPORTEDLY DOING WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion; Pain; Thrombus

  MAUDE report 8823635 ↗
• InjuryApr 19, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2017, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL EXTENSION AND A LIMB EXTENSION. ON (B)(4) 2018, ENDOLOGIX WAS MADE AWARE OF AN INDETERMINATE ENDOLEAK WITH THE PRESENCE OF A TYPE II. THERE IS NO CHANGE IN ANEURYSM SAC SIZE AND NO PLAN TO INTERVENE. ON THE COMPLETION OF CLINICAL ASSESSMENT ((B)(6) 2018), THE INDETERMINATE ENDOLEAK WAS CONFIRMED TO BE A TYPE 1B ENDOLEAK OF THE ILIAC LIMB FOR THE OVATION IX PRODUCT LINE.THE PATIENT IS CURRENTLY BEING MONITORED. NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7443959 ↗
• InjuryNov 2, 2017Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A FOLLOW UP WHERE ANGIOGRAM REVEALED A TYPE IA ENDOLEAK, A TYPE II ENDOLEAK AND AN OCCLUDED LEFT ILIAC LIMB. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PERFORMING A PARTIAL EXPLANT. THE LEFT COLLAR AND SUPRARENAL PORTION OF THE OVATION MAIN BODY WAS LEFT IN PLACE. THE REST OF THE MAIN BODY AND THE RIGHT ILIAC LIMB WERE REMOVED. PHYSICIAN SEWED IN A GRAFT BELOW THE LEFT RENAL AND ATTACHED IT TO THE RIGHT COMMON ILIAC. THE OCCLUDED LEFT LIMB WAS LEFT IN PLACE AS TO NOT DISTURB THE GRAFT AND SEND DEBRIS DOWN THE LEFT ILIAC SYSTEM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6998107 ↗
• InjuryNov 2, 2017Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A FOLLOW UP WHERE ANGIOGRAM REVEALED A TYPE IA ENDOLEAK, A TYPE II ENDOLEAK AND AN OCCLUDED LEFT ILIAC LIMB. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PERFORMING A PARTIAL EXPLANT. THE LEFT COLLAR AND SUPRARENAL PORTION OF THE OVATION MAIN BODY WAS LEFT IN PLACE. THE REST OF THE MAIN BODY AND THE RIGHT ILIAC LIMB WERE REMOVED. PHYSICIAN SEWED IN A GRAFT BELOW THE LEFT RENAL AND ATTACHED IT TO THE RIGHT COMMON ILIAC. THE OCCLUDED LEFT LIMB WAS LEFT IN PLACE AS TO NOT DISTURB THE GRAFT AND SEND DEBRIS DOWN THE LEFT ILIAC SYSTEM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6998098 ↗
• InjuryJul 9, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MONTH POST-OPERATIVE CT IMAGING SHOWED THE PRESENCE OF A POTENTIAL OCCLUSIONS OF THE ILIAC LIMB STENT GRAFT. A RE-INTERVENTION WAS PERFORMED TO PLACE BILATERAL BALLOON EXPANDABLE STENTS WITHIN THE ILIAC LIMBS STENT GRAFT SUCCESSFULLY RESOLVING THE OCCLUSION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5780708 ↗