BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 13846474 · Received March 22, 2022

    Report

    Report Number
    13846474
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 10, 2022
    Manufacturer
    W. L. GORE ASSOCIATES, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PFO (PATENT FORAMEN OVALE) CLOSURE ATTEMPT USING INTRACARDIAC ECHO PROCEDURE (ICE) WITH EMBOLIZATION USING THE GORE CARDIOFORM 25MM DEVICE, THE DEVICE MIGRATED BECAUSE OF THE LARGE SIZE OF THE PFO. INITIALLY THE DEVICE LODGED IN THE LEFT VENTRICLE AND THE PATIENT WAS TAKEN TO THE OR FOR SURGICAL REMOVAL WITH PFO CLOSURE, HOWEVER IN THE OR AN ECHO WAS REPEATED, AND THIS NOTED THE PFO DEVICE HAD MIGRATED TO THE DESCENDING AORTA. THE PATIENT THEN UNDERWENT AN ADDITIONAL VASCULAR PROCEDURE BY LEFT FEMORAL ARTERIAL ACCESS FOR THE PFO DEVICE TO BE REMOVED FROM THE AORTA/VESSEL. RE-ATTEMPT TO CLOSE THE PFO WAS UNSUCCESSFUL. MANUFACTURER RESPONSE FOR TRANSCATHETER SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514421 GORE CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE ASSOCIATES, INC. GSX0025A

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Female Other| R