BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 8908423 · Received August 19, 2019

    Report

    Report Number
    2017233-2019-00670
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 19, 2019
    Report Date
    July 22, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PATIENT WAS ADMITTED TO THE HOSPITAL TO INITIATE ANTICOAGULATION AND TO RULE OUT ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701627 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18354644

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other