BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE CARDIOFORM ASD OCCLUDER

    MDR report key: 9787564 · Received March 4, 2020

    Report

    Report Number
    2017233-2020-00140
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 25, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    UDI-DI
    00733132636501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST STROKE AS A POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN SELECTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN BALLOON FLOWS TOP SIZING TECHNIQUE ATRIAL SEPTAL DEFECT BALLOON SIZED TO 18-19MM. A 32MM GORE® CARDIOFORM ASD OCCLUDER WAS ADVANCED AND DEPLOYED. WHEN THE PHYSICIAN PERFORMED A PUSH-PULL TEST TO CONFIRM DEVICE STABILITY, THE OCCLUDER PULLED THROUGH THE DEFECT. THE DEVICE WAS REMOVED AND A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS ATTEMPTED; HOWEVER, THE DEVICE WAS TOO LARGE FOR THE PATIENT'S ANATOMY TO ACCOMMODATE. THE DEVICE WAS REMOVED AND THE PHYSICIAN OPTED FOR SURGICAL CLOSURE. AT THIS POINT THE PATIENT SUFFERED A MASSIVE STROKE. THE CLOT APPEARED TO HAVE COME OUT OF THE 37MM GORE® CARDIOFORM ASD OCCLUDER DELIVERY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248865 GORE CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES ASD37A 18148321A 00733132636501

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R