BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 8873762 · Received August 8, 2019

    Report

    Report Number
    2017233-2019-00605
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 19, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006. THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST NEW ARRHYTHMIA, SUCH AS ATRIAL FIBRILLATION OR FLUTTER, REQUIRING TREATMENT AS A POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT STOP-FLOW BALLOON SIZED TO 22MM ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION REQUIRING CARDIOVERSION AND WAS PRESCRIBED RATE CONTROL MEDICATION. THE CONDITION IS NOTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667770 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18319057

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention