BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3760768 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00418
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE. A DEVICE TRACKING FORM WS SUBMITTED TO THE MFR INDICATING THAT APPROXIMATELY 3 MONTHS POST IMPLANT THE PUMP WAS EXCHANGED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PRIOR TO IMPLANT THE PT HAD PERSISTENT ATRIAL FIBRILLATION. IN THE MONTH PRIOR TO THE EXCHANGE, THE PT'S PULSATILE ARTERIAL BLOOD PRESSURE AND SIGNS OF HEMOLYSIS WERE MONITORED. AN ANGIOGRAM AND ECHOCARDIOGRAM WERE PERFORMED AND NO INDICATION OF OBSTRUCTION WAS SEEN. A RAMP TEST WAS PERFORMED WHICH INDICATED THAT THE PUMP WAS NOT UNLOADING THE LEFT VENTRICLE: THEREFORE, A DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205565 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 133354

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention