Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1422160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M701TVIL1422160J1), received between Apr 8, 2019 and Sep 7, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 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 THE OVATION IX STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP A POSSIBLE TYPE IB ENDOLEAK (DILATED ILIAC ANEURYSM) WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB. THE PHYSICIAN EXTENDED THE RIGHT LIMB INTO EXTERNAL ILIAC FOR A DILATED ILIAC ANEURYSM. GRAFT SEALED AT EXTERNAL. THE PATIENT WAS REPORTED TO BE DOING GREAT POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 15374209 ↗
• InjuryAug 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN AFX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM AT AN UNKNOWN DATE. ENDOLOGIX WAS MADE AWARE THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE AND AN ENDOLEAK TYPE IIIB WITH STENT FRACTURE. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO RELINE WITH AN OVATION MAIN BODY AND 2 LIMB EXTENSIONS TO SUCCESSFULLY SEAL THE LEAK (REPORTED UNDER MFR# 2031527-2018-00407). APPROXIMATELY (4) FOUR YEARS POST-SECONDARY PROCEDURE THE PATIENT WENT TO THE HOSPITAL DUE TO ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ABLE TO IDENTIFY A TYPE 1B ENDOLEAK. ON (B)(6) 2022, THE PHYSICIAN ELECTED TO COIL EMBOLIZE THE RIGHT HYPOPLASTIC AND COVER THE LEAK WITH (2) TWO OVATION IX ILIAC LIMBS. IT WAS REPORTED THAT THE 1B ENDOLEAK WAS TREATED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15243108 ↗
• InjuryAug 16, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, LEFT ILIAC LIMB GROWTH (ANEURYSM ENLARGEMENT) WITH A TYPE IB ENDOLEAK WAS IDENTIFIED. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT STATUS HAS NOT YET BEEN PROVIDED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15235316 ↗
• InjuryFeb 1, 2022Unintended Movement; Migration; Unintended Movement; Migration

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, AT ROUTINE FOLLOW-UP, IT WAS IDENTIFIED THAT THE LEFT LIMB HAD PULLED BACK UP INTO THE SAC LEAVING LESS THAN 1CM INTO THE ILIAC. THE PHYSICIAN ELECTED TO EXTEND DOWN TO THE HYPOGASTRIC WITH IMPLANT OF AN ADDITIONAL OVATION IX ILIAC LIMB. REINTERVENTION WAS SUCCESSFUL. THE PATIENT WAS REPORTED TO BE DISCHARGED AND DOING GREAT.

  Patient problems: Failure of Implant

  MAUDE report 13416733 ↗
• InjuryAug 6, 2021Complete Blockage; Deformation Due to Compressive Stress; Device-Device Incompatibility; Complete Blockage; Deformation Due to Compressive Stress; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM AND TWO ABBOTT (NON-ENDOLOGIX) PERCLOSE PROGLIDE DEVICES; THIS INDEX PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE ALTO SYSTEM PER DEVICE IFU. APPROXIMATELY SEVENTEEN DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH DIMINISHED FOOT PULSES, CLAUDICATION AND A KINKED LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT VIA SUCCESSFUL OPEN FEMORAL-TIBIAL THROMBECTOMY AND REINFORCING THE OVATION IX LIMB BY IMPLANTING A GORE (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT. NOTE: THE PHYSICIAN BELIEVES THE PROGLIDE DEVICES MAY HAVE CAUSED THE KINK.

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 12291781 ↗
• InjuryJun 28, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT SHOULD BE NOTED THAT THIS PATIENT HAS KNOWN PVD (PERIPHERAL VASCULAR DISEASE). AT THE TIME OF THE INITIAL PROCEDURE THE AAA WAS SEALED AND THERE WAS NO FLOW LIMITING ISSUES IN THE COMMON/EXTERNAL ILIAC ARTERIES. IT SHOULD ALSO BE NOTED THAT THERE WERE UNSUCCESSFUL ATTEMPTS IN PLACING PERCLOSE (NON-ENDOLOGIX) CLOSURE DEVICES PRE-CASE, AND THE PHYSICIAN DECIDED TO USE SINGLE PERCLOSE ON BOTH GROINS. IT WAS REPORTED THAT TWO (2) DAYS AFTER THE INITIAL PROCEDURE THE PATIENT HAD ACUTE RLE (RIGHT LOWER EXTREMITY) ISSUE. THE PHYSICIAN ELECTED TO PERFORM ADDITIONAL SURGERY TO REPAIR. THE PATIENT'S STATUS WAS NOT REPORTED. ADDITIONAL INFORMATION: DURING THE CLINICAL ASSESSMENT IT WAS FOUND THAT THIS EVENT IS NOT A DEVICE FAILURE OF THE OVATION LIMB STENT, RATHER THE RIGHT SUPERFICIAL FEMORAL ARTERY STENT WAS IN PLACE PRIOR TO THE EVAR FOR PERIPHERAL VASCULAR DISEASE.

  Patient problems: Failure of Implant

  MAUDE report 12080483 ↗
• InjuryJan 22, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) MONTHS POST INITIAL PROCEDURE THE PATIENT CAME BACK WITH AN OCCLUDED LEFT ILIAC. THE PATIENT WAS BROUGHT BACK FOR RE-INTERVENTION ON (B)(6) 2021. THE PATIENT WAS FOUND TO HAVE THROMBUS IN THE CONTRALATERAL LIMB. THE PHYSICIAN ELECTED TO USE THROMBOLYSIS ON THE PATIENT OVERNIGHT AND BRING THEM BACK TO THE OPERATING ROOM (OR) ON THE FOLLOWING DAY TO ASSESS. ON (B)(6) 2021 THE THROMBUS HAD RESOLVED AND IT WAS NOTED THE PATIENT HAD STENOSIS AT THE DISTAL EDGE OF THE CONTRALATERAL LIMB. THE PHYSICIAN DECIDED TO USE A (NON ENDOLOGIX) 10X38 ICAST STENT. IT WAS IMPLANTED WITH GOOD RESULTS AND THE PATIENT WAS DISCHARGED TO RETURN HOME.

  Patient problems: Occlusion; Stenosis; Thrombus

  MAUDE report 11216316 ↗
• InjuryDec 17, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM (ONE (1) MAIN BODY WITH TWO (2) ILIAC LIMBS) AND TWO (2) OVATION IV EXTENDERS. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED AND TREATED WITH ANOTHER OVATION IX ILIAC LIMBS. THE INITIAL CASE WAS PERFORMED OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AND CAUTIONARY PRODUCT USE CONDITIONS DUE TO A RUPTURED ANEURYSMAL SAC, PRE EXISTING NON ENDOLOGIX LEFT EXTERNAL ILIAC STENT (CONCOMITANT PRODUCT USE OFF IFU), LEFT COMMON ILIAC DISTAL LANDING ZONE WITH MODERATE CALCIFICATIONS (CAUTIONARY PRODUCT USE) AND ANEURYSMAL NECK WITH 67 DEGREE INFRARENAL ANGULATION COUPLED WITH REVERSE NECK TAPER OF 26% LIKELY CONTRIBUTED TO THE PROXIMAL MIGRATION OF THE LEFT ILIAC STENT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR# 3008011247-2019-00132. NOW, APPROXIMATELY 1.5 YEARS POST-SECONDARY INTERVENTION DURING A ROUTINE FOLLOW UP, ANOTHER TYPE 1B ENDOLEAK WAS IDENTIFIED. A RE-INTERVENTION IS BEING PLANNED AND THE PATIENT IS CURRENTLY BEING MONITORED. ADDITIONAL INFORMATION: DURING THE INVESTIGATION AND REVIEW OF POST IMPLANT CT SCAN SAC

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11033160 ↗
• InjuryFeb 5, 2020Use of Device Problem; Use of Device Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX SUPRARENAL EXTENSION, AND FOUR (4) OVATION IX ILIAC LIMB; OFF-LABEL CASE DUE TO USE OF AFX WITH OVATION DEVICES. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN EXPANDED RIGHT COMMON ILIAC ANEURYSM (RCIA). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY COILING AND EXTENDING WITH AN ADDITIONAL OVATION IX ILIAC LIMB. THE PATIENT IS REPORTEDLY DOING WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST TYPE 1B ENDOLEAK FROM RIGHT ILIAC ARTERY OCCURRED THAT WERE NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9673117 ↗
• InjuryJul 3, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE INVESTIGATION OF A PREVIOUSLY REPORTED EVENT, 3008011247-2019-00058, RIGHT LIMB STENOSIS WAS DISCOVERED PER DISCHARGE SUMMARY FROM (B)(6) 2015 DUE TO MECHANICAL COMPRESSION FROM THE LEFT ILIAC STENT. A RESULTANT BILATERAL SECONDARY ENDOVASCULAR PROCEDURE OCCURRED ON (B)(6) 2015 WITH A BIFURCATED ILIAC BRANCH DEVICE, RIGHT FEMORAL ENDARTECTOMY, AND BOVINE PERICARDIAL PATCH ANGIOPLASTY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ONE-DAY POSTOPERATIVE.

  Patient problems: Stenosis

  MAUDE report 8759813 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST OP, DURING A FOLLOW-UP CT SCAN, A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC (RCI) AND ANEURYSM SAC GROWTH WERE IDENTIFIED. REPORTEDLY, THE TYPE IB ENDOLEAK HAS CAUSED BOTH ENLARGEMENT OF THE RCI AND THE AAA SAC. THE PHYSICIAN STATED THAT THE OVATION IX LIMB APPEARS FLARED AND RETRACTED BACK FROM RIGHT INTERNAL TAKE OFF. RE-INTERVENTION WAS PERFORMED. CASE INFORMATION HAS NOT BEEN PROVIDED BY PHYSICIAN.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8494124 ↗