BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER CONF AAA ENDO - TRUNK-IPSILATERAL

    MDR report key: 23656503 · Received November 26, 2025

    Report

    Report Number
    23656503
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 10, 2025
    Manufacturer
    W. L. GORE ASSOCIATES, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GORE EXCLUDER CONFORMABLE DEVICE MALFUNCTIONED DURING INSERTION. REF NUMBER: CXT281412, SN [REDACTED], EXPIRATION DATE: 2028-03-11. DEVICE PLACED IN RED BIOHAZARD BAG AND PUT WHERE DEVICES THAT ARE BROKEN GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136994 GORE EXCLUDER CONF AAA ENDO - TRUNK-IPSILATERAL SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE ASSOCIATES, INC. CXT281412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown