BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 22580718 · Received July 23, 2025

    Report

    Report Number
    3013164176-2025-02611
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 23, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ZONE 10 RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) AND A RIGHT INTERNAL ILIAC ARTERY ANEURYSM,AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ILIAC BRANCH ENDOPROSTHESES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 35 MM, WITH A PROXIMAL LANDING ZONE THAT MEASURED 20MM. THE MAXIMUM DIAMETER OF THE RCIA MEASURED 20MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, FOLLOW-UP CTA DETERMINED INFOLDING OR COMPRESSION OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT IN THE RCIA AND MILD THROMBUS PRESENT IN THE GRAFTS IN THE RCIA AND RIIA. NO LOSS OF PATENCY WAS NOTED. CODED 1800-E:-IMPLANTABLE DEVICE EVENTS POST DEPLOYMENT - OTHER/UNKNOWN TO CAPTURE "MILD THROMBUS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000787 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635306

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male