BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 8976396 · Received September 9, 2019

    Report

    Report Number
    2017233-2019-00825
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 15, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT MEASURED TO 18X21MM. WHEN THE DEVICE WAS LOCKED, THE PATIENT WENT INTO JUNCTIONAL RHYTHM. THE RETRIEVAL CORD WAS LOOSENED AND THE JUNCTIONAL RHYTHM CONTINUED. TWENTY MINUTES POST-IMPLANT A TEMPORARY PACER WAS PLACED, PACED TO 120, THEN TURNED OFF. THE PATIENT WAS THEN IN NORMAL RHYTHM. THE TEMPORARY PACER WAS LEFT IN AND THE PATIENT WAS GOING IN AND OUT OF FIRST DEGREE HEART BLOCK OVERNIGHT. ADDITIONAL HOLTER MONITORING SHOWED FIRST DEGREE HEART BLOCK WITH INTERMITTENT SECOND DEGREE HEART BLOCK, AND THE LAST MONITOR UPDATE NOTED THE PATIENT WAS IN COMPLETE SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771939 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18558557A

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R