BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 367225 · Received December 17, 2001

    Report

    Report Number
    2916596-2001-00035
    Event Type
    Other
    Date Received
    December 17, 2001
    Date of Event
    November 16, 2001
    Report Date
    December 17, 2001
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THROMBUS WAS SEEN FORMING IN THE RVAD OF A PATIENT BEING SUPPORTED WITH BIVENTRICULAR VADS. THE RVAD WAS REPLACED WITHOUT INCIDENT. THERE WAS NO INDICATION THAT THE THROMBUS WAS RELATED TO ANY FAILURE OF THE DEVICE. THE EXPLANTED DEVICE IS BEING STERILIZED BEFORE RETURNED TO THORATEC FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56960 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE, BLOOD PUMP DSQ THORATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention