Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1428140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M701TVIL1428140J1), received between Dec 18, 2015 and Dec 22, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Off-Label Use; Device-Device Incompatibility; Separation Problem; Off-Label Use; Device-Device Incompatibility; Separation Problem

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX LIMB STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2017, A REINTERVENTION WAS PERFORMED TO TREAT A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY ALONG WITH A COILED RIGHT INTERNAL ILIAC ARTERY SEEN AT THE INITIAL IMPLANT. THE ILIAC ANATOMY AND THE SUBOPTIMAL POSITION OF THE STENT IN AN ANEURYSMAL VESSEL AT THE IMPLANT PROCEDURE WAS OFF-LABEL. AN OVATION IX ILIAC LIMB WAS IMPLANTED. THIS PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2018-00354. REINTERVENTION WAS COMPLETED ON AN UNKNOWN DATE WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) STENT DUE TO THE SEPARATION OF THE AFX LIMB STENT GRAFT AND THE OVATION IX ILIAC LIMB.

  Patient problems: Insufficient Information

  MAUDE report 18387029 ↗
• InjuryApr 19, 2023Complete Blockage; Off-Label Use; Complete Blockage; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BILATERAL CLAUDICATION. SUBSEQUENT CT (COMPUTED TOMOGRAPHY) SCAN REVEALED BILATERAL OCCLUSIONS OF THE ILIAC LIMBS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT VIA THROMBECTOMY, AND THE LEFT ILIAC LIMB WAS CONFIRMED AS SUCCESSFULLY OPENED; HOWEVER, THE RIGHT ILIAC REMAINED CLOSED. THE PHYSICIAN PLANS TO PERFORM A FEMORAL-FEMORAL BYPASS AT A LATER TIME TO RESTORE FLOW TO THE RIGHT LIMB. IT IS SUSPECTED THAT PATIENT HAS COVID AND A CLOTTING DISORDER.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16770776 ↗
• InjuryJul 7, 2022Insufficient 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 3.5 YEARS POST INITIAL PROCEDURE, THE ILIAC LIMB WAS STARTING TO LOSE SEAL WITH NO VISIBLE LEAK. THE PHYSICIAN ELECTED TO COIL AND IMPLANT AN ILIAC LIMB TO EXTEND SEAL TO THE EXTERNAL ILIAC. THE PATIENT STATUS WAS REPORTED AS BEING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14948391 ↗
• InjuryAug 30, 2021Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY (4) FOUR YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND LIMB MIGRATION. THE PATIENT IS CURRENTLY STABLE PENDING AN INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 12385346 ↗
• InjuryApr 7, 2021Migration; Migration

  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 IMPLANT, MIGRATION AND A POSSIBLE TYPE 1B ENDOLEAK WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY (CT) SCAN. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANTED TWO (2) OVATION IX ILIAC LIMBS. THE PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Failure of Implant

  MAUDE report 11632013 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Unintended Movement; Patient-Device Incompatibility; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A DISLODGED LEFT ILIAC LIMB DEVICE AND A TYPE IB ENDOLEAK AS DETECTED BY CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTED IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: A SECONDARY ENDOVASCULAR PROCEDURE OCCURRED ON (B)(6) 2020. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) OVATION LIMBS AND COILING OF LEFT COMMON ILIAC ARTERY TO RESOLVE THESES EVENTS. ADDITIONAL FINDINGS SAC GROWTH OF 5MM OF LEFT COMMON ARTERY OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9775110 ↗
• InjuryNov 20, 2018Collapse; Leak/Splash; Off-Label Use; Collapse; Leak/Splash; Off-Label Use

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP ONE MONTH POST INDEX PROCEDURE WHERE THE PHYSICIAN OBSERVED AN OCCLUSION OF THE LEFT ILIAC LIMB. THE RIGHT LIMB APPEARED TO BE PLACED TOO HIGH ABOVE THE FLOW DIVIDER OF THE MAIN BODY, CAUSING COMPROMISED FLOW TO THE LEFT LIMB. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A 14X80 LIMB ON THE LEFT SIDE TO SUPPORT THE RIGHT SIDE THAT WAS ABOVE THE FLOW DIVIDER. AFTER PLACEMENT OF THE NEW LIMB, IT WAS OBSERVED THAT THE NEW LIMB WAS COMPRESSED AT ITS PROXIMAL EDGE WHICH CAUSED DIMINISHED FLOW TO THE LEFT SIDE. THE PHYSICIAN THEN PLACED BILATERAL KISSING 10X28 BALLOON EXPANDABLE STENTS TO HELP OPEN AND SUPPORT EACH LIMB EQUALLY. AFTER THE STENTS WERE PLACED, THE PHYSICIAN ADVANCED A PIGTAIL CATHETER UP THE RIGHT SIDE OF THE PATIENT AND INADVERTENTLY DISLODGED THE BALLOON EXPANDABLE STENT CAUSING IT TO FLOAT FREELY IN THE AORTA. IT WAS DECIDED TO ADVANCE A BALLOON MOUNTED PALMAZ STENT UP THE LEFT SIDE TO SECURE THE FREE FLOATING STENT, HOWEVER, THIS CAUSED THE BALLOON EXPANDABLE STENT IN THE LEFT SIDE TO BE DISLODGED AS WELL. THE PHYSICIAN ELECT

  Patient problems: Aneurysm; Failure of Implant; Stenosis

  MAUDE report 8090338 ↗
• InjuryJul 5, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION PRIME AORTIC BODY STENT GRAFT AND OVATION IX ILIAC LIMB STENT GRAFTS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 2 MONTH POST-OPERATIVE CT IMAGING SHOWED THE PRESENCE OF COMPRESSION/NARROWING OF THE LEFT ILIAC LIMB STENT GRAFT DUE TO INFRARENAL ANGULATION NOTED AT THE AORTIC BODY/ ILIAC LIMB STENT GRAFT OVERLAP. THERE WAS EVIDENCE OF THROMBUS FORMATION; HOWEVER, IT WAS NOTED THAT THE ILIAC LIMB REMAINED PATENT. A THROMBECTOMY RE-INTERVENTION WAS PERFORMED FOLLOWED BY THE PLACEMENT OF A BILATERAL BALLOON EXPANDABLE STENTS WITHIN THE ILIAC LIMBS EXTENDING UP TO THE AORTIC BODY SEALING RINGS SUCCESSFULLY RESOLVING THE STENOSIS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Stenosis

  MAUDE report 5771037 ↗
• InjuryApr 3, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE SIX MONTH FOLLOW-UP SHOWED EVIDENCE OF A STENOSIS OF THE LEFT ILIAC LIMB AND A POTENTIAL TYPE II AND/OR TYPE IB ENDOLEAK ALSO ON THE LEFT SIDE. THE LEFT LIMB STENOSIS WAS REPORTED TO HAVE BEEN RESOLVED WITHOUT RE-INTERVENTION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Stenosis

  MAUDE report 5543526 ↗
• InjuryDec 18, 2015Adverse Event Without Identified Device or Use Problem

  AN OVATION IX AORTIC BODY STENT GRAFT AND OVATION IX ILIAC LIMB STENT GRAFTS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MONTH PATIENT POST-OP CT IMAGING SHOWED THE PRESENCE OF COMPRESSION/NARROWING OF THE LEFT ILIAC LIMB STENT GRAFT DUE TO SIGNIFICANT ANGULATION NOTED IN THE LEFT COMMON ILIAC ARTERY IN THE PRESENCE OF SEVERE TORTUOSITY; HOWEVER, IT WAS NOTED THAT THE ILIAC LIMB REMAINED PATENT. A THROMBECTOMY RE-INTERVENTION WAS PERFORMED FOLLOWED BY THE PLACEMENT OF A BALLOON EXPANDABLE STENT WITHIN THE LEFT ILIAC LIMB AT THE LOCATION OF THE ANATOMICAL NARROWING, WHICH INCREASED FLOW THROUGH THE AREA WHERE THE NARROWING WAS PREVIOUSLY SEEN. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: No Code Available

  MAUDE report 5312305 ↗