BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4172045 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01794
    Event Type
    Other
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT RECEIVED A PUMP EXCHANGE DUE TO SUSPECTED DEVICE THROMBOSIS AND HEMOLYSIS. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A SUB THERAPEUTIC INR, DID NOT HAVE AN INFECTION AND HAD NO KNOWN ETIOLOGY OF THROMBUS. A RAMP STUDY WAS PERFORMED AND THE AORTIC VALUE WAS OPENING EVERY BEAT AT 11,200 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643290 HEARTMATE II LVAS Ventricular (assist) bypass DSQ THORATEC CORP. 106015 141446

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention NA.