BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 297393 · Received September 20, 2000

    Report

    Report Number
    2916596-2000-00024
    Event Type
    Injury
    Date Received
    September 20, 2000
    Date of Event
    August 14, 2000
    Report Date
    September 20, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER INDICATED ON THE MEDICAL DEVICE TRACKING FORM THAT THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) ON THE PT WAS REPLACED DUE TO CLOT FORMATION. THE PT WAS ON BIVENTRICULAR ASSIST DEVICES (LVAD AND RVAD) SUPPORT FOR 39 DAYS. FOLLOW UP CONVERSATION WITH THE PERSONNEL AT THE HOSP REVEALED THAT UPON REMOVAL OF THE RVAD, NO THROMBUS WAS OBSERVED, BUT ONLY A THIN LAYER OF FIBRIN WHICH WOULD NOT HAVE REQUIRED REPLACEMENT OF THE RVAD. THEREFORE, THERE WAS NO INDICATION OF VAD MALFUNCTION. THE PT WAS SUCCESSFULLY TRANSPLANTED SEVEN DAYS AFTER THE RVAD WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other