BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9535807 · Received December 31, 2019

    Report

    Report Number
    2017233-2019-01283
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    June 26, 2019
    Report Date
    December 20, 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

    PMA#: P050006.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED THROUGH THE CLINICAL STUDY ASD 15-04: IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT REPORTED PALPITATIONS ALMOST NIGHTLY WHEN LYING DOWN THEY WERE NOTED TO SELF-RESOLVE AFTER A TIME. THE ARRHYTHMIA WAS DOCUMENTED WITH ECG. THE PATIENT WAS GIVEN METOPROLOL 25MG FOR HEADACHES AND PALPITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329947 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 16202262

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other