BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3962671 · Received July 16, 2014

    Report

    Report Number
    2916596-2014-01191
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE VAD ENGINEER REPORTED THAT THE PT WAS LISTED AS STATUS 1A AFTER PUMP THROMBUS WAS DISCOVERED. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS GIVEN, BUT THE PT SUBSEQUENTLY HAD SEVERE RIGHT VENTRICLE (RV) FAILURE. A DONOR ORGAN BECAME AVAILABLE AND THE PT UNDERWENT A TRANSPLANT ON (B)(6) 2014. DURING THE TRANSPLANT, THE PT WAS ON MILRINONE TO HELP RV. THROMBUS WAS VISUALIZED AT INFLOW STATOR AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415372 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109245

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention