BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 8911039 · Received August 20, 2019

    Report

    Report Number
    2017233-2019-00674
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 26, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WEIGHT WAS AVAILABLE. PMA/510(K) #: P050006.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2019. AT A FOLLOW-UP VISIT ON (B)(6) 2019, A THROMBUS WAS NOTED ON THE RIGHT ATRIAL DISK. THE PHYSICIAN STARTED THE PATIENT ON ELIQUIS 5 MG TO INITIATE ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705123 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18083640

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other