BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 24143922 · Received January 22, 2026

    Report

    Report Number
    24143922
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    October 23, 2025
    Report Date
    January 5, 2026
    Manufacturer
    W. L. GORE ASSOCIATES, INC.
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR A PFO [PATENT FORAMEN OVALE] CLOSURE PROCEDURE. IN THE PROCEDURE THE DEVICE GORE CARDIOFORM SEPTAL OCCLUDER REFERENCE NUMBER GSX0030A, SERIAL NUMBER [REDACTED], EXPIRATION DATE 2027-08-20 WAS USED AS THE CLOSURE DEVICE. DURING THE PROCEDURE THE SURGEON WAS UNABLE TO RELEASE THE CLOSURE DEVICE AND HAD TO USE A SNARE AND ONO CATHETER TO RETRIEVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204151 GORE CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE ASSOCIATES, INC. GSX0030A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female