BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9590547 · Received January 15, 2020

    Report

    Report Number
    2017233-2020-00034
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 2, 2019
    Report Date
    January 28, 2020
    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 · 0

    A REVIEW OF THE IMAGING STATED THE FOLLOWING: IT WAS REPORTED AT A FOLLOW UP TO THE IMPLANT OF A GORE CARDIOFORM ASD OCCLUDER THAT THERE WAS THROMBUS ATTACHED TO THE RIGHT ATRIAL DISC. FROM THE IMAGING PROVIDED THE DEVICE APPEARS TO BE IN A GOOD POSITION ON THE ATRIAL SEPTUM. THERE DOES APPEAR TO BE AN ECHOGENIC MASS ATTACHED TO THE RIGHT ATRIAL DISC THAT IS CONSISTENT WITH THE APPEARANCE OF THROMBUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM ASD OCCLUDER. AT A FOLLOW-UP APPOINTMENT, ON (B)(6) 2019, A THROMBUS WAS NOTED ON THE RIGHT DISC. THE PATIENT WAS TREATED WITH A DIRECT-ACTING ORAL ANTICOAGULANT (DOAC).

    Additional Manufacturer Narrative · 1

    PMA / 510K = P050006.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM ASD OCCLUDER. AT A FOLLOW-UP APPOINTMENT, ON APPROXIMATELY (B)(6) 2019, A THROMBUS WAS NOTED ON THE RIGHT DISC. THE PATIENT WAS TREATED WITH A DIRECT-ACTING ORAL ANTICOAGULANT (DOAC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55178 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18548238

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other