BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 2924898 · Received January 17, 2013

    Report

    Report Number
    2916596-2013-00073
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH TWO PARACORPOREAL VENTRICULAR ASSIST DEVICES (PVADS) FOR BIVENTRICULAR SUPPORT. THE VAD COORDINATOR REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING SHORTNESS OF BREATH (SOB) FOR A PERIOD OF TWO WEEKS ALONG WITH MORE FIXED ALARMS. THE PATIENT'S TLCII PLUS DRIVER WAS EXCHANGED, THE ACCUMULATOR PRESSURE AND BEAT RATE WERE INCREASED AND THE PATIENT WAS STARTED ON SILDENAFIL. THE PATIENT APPEARED TO DO WELL FOR A FEW DAYS AND THEN BECAME INCREASINGLY SYMPTOMATIC WITH MORE SOB. THE PVAD RVAD (SUPPORTING THE RIGHT VENTRICLE) WAS CHANGED TO FIXED MODE FOR A PERIOD OF SIX HOURS. AN ECHOCARDIOGRAM (ECHO) PERFORMED BY THE HOSPITAL DID NOT SHOW ANY KINKING OF THE CANNULA. THE PATIENT REMAINS IN THE HOSPITAL UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25410 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 100228

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention