BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3033863 · Received April 3, 2013

    Report

    Report Number
    3033863
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    October 21, 2008
    Report Date
    March 25, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TEE REVEAL WHAT APPEARED TO BE A LARGE THROMBUS WITHIN THE LEFT ATRIAL APPENDAGE, ALMOST COMPLETELY OCCLUDING THE INFLOW VALVE TO THE LEFT VENTRICLE. THE TAH-T WAS DICONNECTED ON BYPASS AND REVEALED THAT THE LEFT ATRIAL APPENDAGE WAS INVERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136667 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1