BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 392127 · Received May 2, 2002

    Report

    Report Number
    2916596-2002-00010
    Event Type
    Injury
    Date Received
    May 2, 2002
    Date of Event
    March 11, 2002
    Report Date
    April 30, 2002
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001, A BIVAD PATIENT WAS IMPLANTED WITH THE THORATEC VAD SYSTEM. DURING LATE NOVEMBER/EARLY DECEMBER 2001, THE RVAD WAS NOTED NOT TO BE EMPTYING COMPLETELY. THE HOSPITAL KEPT THE PATIENT ON THE PORTABLE DRIVER (TLC-II) UNITL 03/2002, AT WHICH TIME THE PATIENT WAS SWITCHED TO THE DUAL DRIVER CONSOLE (DDC). PRIOR TO THE DDC SWITCH, THE PATIENT DEVELOPED PULMONARY HYPERTENSION. A CT SCAN REVEALED MULTIPLE MICRO-EMBOLI. PATIENT TRANSFERRED FROM CARDIAC TRANSPLANT LIST TO HEART-LUNG TRANSPLANT LIST. WHILE BIVAD PATIENT AWAITS HEART/LUNG TRANSPLANT, THEY CONTINUE ON THE DDC AND IS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization