Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1414120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1414120J1), received between Aug 4, 2016 and Sep 10, 2020 — classified as 1 death, 7 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.

• DeathSep 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM DUE TO A TYPE 1B ENDOLEAK. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO USE A NON- ENDOLOGIX STENT TO RESOLVE THIS EVENT, IT WAS REPORTED THAT THE PATIENT WAS NOT DOING WELL POST INTERVENTION AS THE PATIENT SUFFERS FROM COMPARTMENT SYNDROME. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT IDENTIFIED THE PATIENT EXPIRED ON 2020, SIX DAY POST RE-INTERVENTION.

  Patient problems: Blood Loss; Death; Ischemia; Rupture

  MAUDE report 10517614 ↗
• InjurySep 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY FOUR (4) MONTHS POST-OP AN OCCLUDED RIGHT LIMB WAS IDENTIFIED, THE EXACT DATE IS UNKNOWN. THE PHYSICIAN ELECTED TO PERFORM A FEM-FEM BYPASS. THE RE-INTERVENTION WAS REPORTED SUCCESSFUL AND THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Occlusion

  MAUDE report 8972497 ↗
• InjuryJul 25, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ILIAC ANEURYSM (OFF-LABEL USE) WITH THE AFX2 AND OVATION IX ABDOMINAL AORTIC ANEURYSM STENTS. TWENTY-THREE (23) DAYS POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH NO COMPONENT SEPARATION) WAS DETECTED AT THE JUNCTION OF THE AFX2 BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB WITH NO CHANGE IN THE DIAMETER OF THE ILIAC ANEURYSM; THESE FINDINGS WERE IDENTIFIED DURING ROUTINE FOLLOW-UP CTA (COMPUTED TOPOGRAPHY ANGIOGRAPHY). THE PATIENT IS REPORTEDLY IN GOOD CONDITION, AND THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT SECONDARY ENDOVASCULAR PROCEDURE WAS PERFORMED ON (B)(6) 2019 WITH NON-ENDOLOGIX EXTENSION.

  Patient problems: No Code Available

  MAUDE report 8829234 ↗
• InjuryFeb 21, 2018Occlusion Within Device; Off-Label Use; Occlusion Within Device; Off-Label Use

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY TWO MONTHS POST-INDEX PROCEDURE WHERE PHYSICIAN OBSERVED A LIMB OCCLUSION. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING FOUR LIFESTREAM COVERED STENTS IN THE LEFT LIMB AND ONE STENT AT THE PROXIMAL RIGHT LIMB TO KISS AT THE OVATION MAIN BODY FLOW DIVIDER, SUCCESSFULLY RESOLVING THE OCCLUSION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7285673 ↗
• InjuryDec 14, 2017Improper Flow or Infusion; Improper Flow or Infusion

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON THE FINAL ANGIO OF THE INDEX PROCEDURE, BILATERAL NARROWING OF THE ILIAC LIMBS WAS OBSERVED DUE TO THE LEGS CROSSING OVER EACH OTHER. THE PHYSICIAN ELECTED TO CONCLUDE THE CASE AND MONITOR THE PATIENT. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT RETURNED WITH CLAUDICATION. THE PHYSICIAN RE-INTERVENED BY PLACING TWO ICAST STENTS EXTENDING FROM THE ILIAC LIMBS TO JUST UNDER THE SECONDARY SEALING RING. TWO BALLOONS WERE ALSO PLACED IN THE SPACE BETWEEN THE SECONDARY SEALING RINGS AND THE BIFURCATION TO FLARE THE PROXIMAL PORTION OF THE ICAST STENTS. THE FINAL ANGIO SHOWED IMPROVED FLOW AND THE PATIENT IS REPORTED AS DOING WELL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Claudication; Failure of Implant; Stenosis

  MAUDE report 7117255 ↗
• InjuryNov 2, 2017Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE INDEX PROCEDURE WENT AS EXPECTED. PATIENT RETURNED APPROXIMATELY 2 MONTHS LATER WITH AN OCCLUDED LEFT LIMB AND A LATE TYPE IA ENDOLEAK. PHYSICIAN ELECTED TO RE-INTERVENE AND PLACE ICAST STENTS INTO THE OCCLUDED LEFT LIMB TO OPEN THE VESSEL. COILS AND A PALMAZ STENT WERE ALSO PLACED AT THE LEVEL OF THE SEALING RINGS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION AND THE TYPE IA ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6998070 ↗
• InjuryMay 17, 2017Off-Label Use; Off-Label Use

  AN AFX2 BIFURCATED STENT GRAFT SYSTEM AND OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PATIENT RETURNED FOR A FOLLOW-UP APPROXIMATELY 10 MONTHS POST-OP WHERE A CT SHOWED THE PRESENCE OF A POTENTIAL TYPE IIIA AND/OR IIIB ENDOLEAK NEAR THE ORIGIN OF THE HYPO-SNORKEL FROM THE RIGHT COMMON AND RIGHT INTERNAL ILIAC ARTERIES. A POSSIBLE RE-INTERVENTION IS BEING PLANNED BUT IS CURRENTLY NOT SCHEDULED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6572543 ↗
• InjuryAug 4, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 7 MONTH POST-OPERATIVE CT IMAGING SHOWED THE PRESENCE OF AN ILIAC LIMB STENOSIS. THE PATIENT WAS STARTED ON DRUG THERAPY AND WILL UNDERGO RE-INTERVENTION AT A LATER DATE TO TREAT THE STENOSIS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Stenosis

  MAUDE report 5848939 ↗