BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1071638 · Received July 9, 2008

    Report

    Report Number
    2916596-2008-00089
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT REMAINS ONGOING WITH THE MANUFACTURER'S LVAD. THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATION. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD EDUCATOR THAT THE PT CALLED THE HOSPITAL WITH COMPLAINTS OF RIGHT SIDED FAILURE. THE LABS FROM A NEARBY HOSPITAL REVEALED HIGH LIVER NUMBERS (INR 7). PHYSICIAN REQUESTED PT BE ADMITTED TO HOSPITAL; HOWEVER, THREE HOURS LATER, THE PT WAS FOUND STILL AT HOME WITH SHORTNESS OF BREATH. PT WAS BROUGHT TO THE HOSPITAL AND INTUBATED. WHEN THE PUMP SPEED WAS INCREASED FROM 9400 RPMS TO 9600 RPMS, LOW FLOW ALARMS OCCURRED WITH A FLOW OF 2.4. WAVEFORM AND LOG FILE ANALYSIS CONFIRMED LOW FLOW ALARMS, AND A DECISION WAS THEN MADE TO EXCHANGE THE PUMP. THE LVAD WAS REPLACED WITH ANOTHER LVAD, AND THE PT'S ORIGINAL INFLOW CONDUIT AND OUTFLOW GRAFT REMAINED IN PLACE. THE SURGEON NOTED THAT THROMBUS HAD BEEN SUCKED INTO THE INLET STATOR FROM A PANNUS WHICH HAD FORMED AROUND THE INFLOW. THE SURGEON ALSO REPORTED THAT THE POSITON OF THE INFLOW CANNULA WAS NOT A FACTOR. THE PT REMAINS STABLE WITH THE MANUFACTURER'S LVAD.

    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 41 YR Required Intervention