BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1240864 · Received November 6, 2008

    Report

    Report Number
    2916596-2008-00160
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS STABLE AT HOME. 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 LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD EDUCATOR THAT THE PT HAD EXHIBITED HIGH FLOW AND AN INCREASE IN POWER. THE PT WAS ADMITTED INTO THE HOSPITAL FOR EVALUATION AND THE SURGEON CONFERRED WITH THE MFR'S REPRESENTATIVES REGARDING POSSIBLE THROMBUS. THE ECHOCARDIOGRAM, WAVEFORM, X-RAYS, AND LOG FILE WERE EVALUATED AND IT WAS DETERMINED THAT THERE WAS NO OBSTRUCTION OR ANY DYSFUNCTION WITH THE DEVICE. THE SURGEON REPORTED THAT THE POWER DECREASED WITH THE INCREASE IN ANTICOAGULATION. DUE TO THE PT'S HISTORY, THE SURGEON WAS CONCERNED THAT THE PT MIGHT DEVELOP A CLOT, AND AS A RESULT THE SURGEON DECIDED TO KEEP THE PT IN THE HOSPITAL FOR OBSERVATION AND ON AN ANTICOAGULANT UNTIL THE PT COULD BE TRANSPLANTED. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT HAD DISCONNECTED HIS PUMP FROM THE SYSTEM CONTROLLER FOR AN UNDISCLOSED AMOUNT OF TIME. FOUR DAYS LATER, AT THE REQUEST OF A REPRESENTATIVE FROM THE MFR, THE DATA LOGGER WAS SET TO ITS FASTEST SPEED (15 SECONDS) FOR A FEW HOURS LATER AND THE DATA WAS REVIEWED. SINCE THE PT'S ECHOCARDIOGRAM, X-RAYS, WAVEFORMS AND DATA LOGS DID NOT SHOW ANY DYSFUNCTION OF THE DEVICE, THE MFR'S REPRESENTATIVE DETERMINED THAT A PUMP EXCHANGE WAS NOT WARRANTED AT THAT TIME AND RECOMMENDED TO CONTINUE TO MONITOR THE PT. THE PT'S ANTICOAGULANT WAS INCREASED AND THE PT WAS DISCHARGED A WEEK LATER. THE PT REMAINS STABLE AT HOME AND IS AWAITING A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 1355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other