BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 16675084 · Received April 4, 2023

    Report

    Report Number
    2017233-2023-03842
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    December 18, 2021
    Report Date
    June 29, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION DETERMINED NO PRODUCT PROBLEM OR DEFICIENCY CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT/INCIDENT FOR THE PATIENT; THE INITIAL MEDWATCH AND ANY SUPPLEMENTAL REPORT SUBMITTED UNDER MANUFACTURER REPORT NUMBER 2017233-2023-03842 WAS SUBMITTED IN ERROR AND IS HEREBY RETRACTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED. EARLY RESULTS AND TECHNICAL TIPS OF COMBINING ILIAC BRANCH ENDOPROSTHESES WITH FENESTRATED AORTIC STENT GRAFTS DURING ENDOVASCULAR REPAIR OF COMPLEX ABDOMINAL AND THORACOABDOMINAL AORTIC ANEURYSMS, LOUIS L. ZHANG ET AL, ANNALS OF VASCULAR SURGERY 2022; 82: 104-111. BACKGROUND: CONCOMITANT ILIAC ARTERY ANEURYSMS CAN POSE CHALLENGES DURING REPAIR OF COMPLEX ABDOMINAL AND THORACOABDOMINAL AORTIC ANEURYSMS. IN FENESTRATED AORTIC ANEURYSM REPAIRS (FEVAR), PRESERVATION OF INTERNAL ILIAC PERFUSION IS IMPORTANT TO MINIMIZE RISK OF SPINAL CORD ISCHEMIA. CURRENTLY, MOST COMMONLY USED FENESTRATED STENT GRAFTS AND THE ONLY APPROVED ILIAC BRANCH DEVICES ARE MANUFACTURED BY DIFFERENT COMPANIES IN THE UNITED STATES. WE REPORT OUR EXPERIENCE WITH COMBINING ILIAC BRANCH ENDOPROSTHESIS (IBE) (W.L. GORE AND ASSOCIATES, FLAGSTAFF, AZ) AND FENESTRATED STENT GRAFTS, USING THE ZENITH PLATFORM (COOK MEDICAL, BLOOMINGTON, IN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087010 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R