BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 8781552 · Received July 11, 2019

    Report

    Report Number
    2017233-2019-00517
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 17, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A 48 MM GORE® CARDIOFORM ASD OCCLUDER (B)(6) 2019 TO CLOSE AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 26 MM. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED AND AN ELECTROCARDIOGRAM DEMONSTRATED SUPRAVENTRICULAR ARRHYTHMIA WHICH WAS TREATED WITH CARDIOVERSION, ORAL, AND IV RATE CONTROL MEDICATIONS. THE ARRHYTHMIA WAS DOCUMENTED AS RESOLVED (B)(6) 2019. ON (B)(6) 2019 AN ELECTROCARDIOGRAM DEMONSTRATED SUPRAVENTRICULAR ARRHYTHMIA WHICH DID NOT REQUIRE TREATMENT BUT IS DOCUMENTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574365 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18088243

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O| R