BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD)

    MDR report key: 243342 · Received October 2, 1999

    Report

    Report Number
    2916596-1999-00009
    Event Type
    Other
    Date Received
    October 2, 1999
    Date of Event
    August 27, 1999
    Report Date
    September 2, 1999
    Manufacturer
    THORATEC LABORATORIES, CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT SUPPORTED WITH BIVENTRICULAR ASSIST DEVICES (LVAD & RVAD) DEVELOPED A DIME SIZED THROMBUS IN THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) NEAR THE OUTFLOW VALVE. ANTICOAGULATION WAS DIFFICULT DUE TO A HISTORY OF SEVERE NOSE BLEEDS. THE PT WAS TAKEN BACK TO THE OR AND UPON REOPENING THE CHEST, THE RVAD OUTFLOW GRAFT TO THE PULMONARY ARTERY WAS FOUND TO BE COMPRESSED WITH A ONE-INCH CLOT IN IT. THE RVAD AND THE PULMONARY ARTERIAL GRAFT WAS REPLACED AND THE RIGHT ATRIAL CANNULATION WAS CHANGED TO RIGHT VENTRICULAR CANNULATION. SUBSEQUENTLY, THE PT HAD GOOD VAD OUTPUTS AND WAS TRANSPLANTED 13 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) Implant VENTRICULAR ASSIST DEVICE, BLOOD PUMP DSQ THORATEC LABORATORIES, CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention