Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1416100-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M701TVIL1416100J1), received between Oct 22, 2016 and Sep 14, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A JUNCTION ENDOLEAK (CATEGORIZED AS A TYPE 3A ENDOLEAK) WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB STENT GRAFT TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3008011247-2021-00140. ON 28 AUGUST 2023, DURING ROUTINE FOLLOW UP, ANOTHER JUNCTIONAL ENDOLEAK WAS SUSPECTED AT THE PROXIMAL PART OF THE LIMB. THE PATIENT WAS BROUGHT BACK ON (B)(6) 2023 AND AN ANGIOGRAM WAS PERFORMED. AN ENDOLEAK WAS DIFFICULT TO VISUALIZE; HOWEVER, THE PHYSICIAN DETERMINED THIS TO BE A TYPE 3A ENDOLEAK AND ELECTED TO TREAT THE PATIENT BY PLACING 14X45 OVATION LIMBS TO EACH OF THE GATES RAISING THE BIFURCATION. THE PATIENT WAS REPORTED AS DOING FINE POST THIS TERTIARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17749389 ↗
• InjuryApr 4, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR AN UNKNOWN REASON APPROXIMATELY 2 YEARS POST INDEX PROCEDURE WITH A TYPE IB ENDOELAK OF THE RIGHT ILIAC LIMB. THE PHYSICIAN IS PLANNING TO RE-INTERVENE BY EXTENDING THE RIGHT ILIAC LIMB, HOWEVER, A DATE FOR THE RE-INTERVENTION HAS NOT BEEN SCHEDULED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7396061 ↗
• InjuryJan 17, 2018Collapse; Kinked; Leak/Splash; Occlusion Within Device; Collapse; Kinked; Leak/Splash; Occlusion Within Device

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CLAUDICATION AND A COLD LEFT FOOT. A CT WAS DONE WHICH SHOWED ONE LIMB BLOCKING THE FLOW OF THE OTHER LIMB LEADING TO AN OCCLUSION. A RE-INTERVENTION WAS PERFORMED WHERE THE PHYSICIAN ATTEMPTED TO BALLOON THE OCCLUDED LIMB, HOWEVER THE PATIENT COULD NOT TOLERATE THE PROCEDURE AND EXPIRED.

  Patient problems: Aneurysm; Claudication; Death; Failure of Implant; Occlusion; Pain; Stenosis

  MAUDE report 7199542 ↗
• InjuryOct 22, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 2 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF A COMPLETE THROMBOSIS OF THE LEFT ILIAC LIMB STENT GRAFT. THE PATIENT WAS STARTED ON DRUG THERAPY, AND A RE-INTERVENTION WAS PERFORMED TO PLACE AN ADDITIONAL ILIAC LIMB STENT GRAFT TO RE-LINE THE PREVIOUSLY PLACED ILIAC LIMB, AND FLOW WAS SUCCESSFULLY RESTORED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6049532 ↗