BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4121247 · Received September 23, 2014

    Report

    Report Number
    2916596-2014-01592
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED WITH THE DRIVELINE CUT APPROXIMATELY 7¿ FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. THE SEALED INFLOW CONDUIT WAS ALSO NOT RETURNED. THE SEALED OUTFLOW GRAFT WAS RETURNED UNATTACHED FROM THE OUTFLOW ELBOW. THE OUTFLOW GRAFT BEND RELIEF WAS RETURNED UNATTACHED FROM THE GRAFT ATTACHMENT AND AN UNATTACHED BEND RELIEF COLLAR WAS ALSO RETURNED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED DEPOSITIONS OF UNSTRUCTURED AND DENATURED BLOOD EXTENDING FROM THE INLET STATOR, THROUGHOUT THE PUMP, AND INTO THE OUTFLOW ELBOW. THE AREAS OF THE DEPOSITIONS THAT WERE IN DIRECT CONTACT WITH THE INFLOW AND OUTFLOW BEARINGS APPEARED SIGNIFICANTLY DENATURED. THE DEPOSITIONS FOUND IN THE PUMP AND IN THE OUTFLOW ELBOW APPEARED TO HAVE DEVELOPED DUE TO A LOW FLOW STATE OR AN INTERRUPTION IN FLOW THROUGH THE PUMP; HOWEVER, A SPECIFIC CAUSE FOR THE INTERRUPTION IN FLOW COULD NOT BE CONCLUSIVELY DETERMINED. THE DEPOSITIONS FOUND IN THE PUMP WOULD HAVE CREATED INCREASED RESISTANCE ON THE SPINNING ROTOR, POTENTIALLY CONTRIBUTING TO THE REPORTED POWER ELEVATIONS AND POSSIBLE CESSATION OF THE MOTOR. THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ABNORMALITIES WERE FOUND. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA FROM THIS TESTING REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS, AND THE PUMP OPERATED AS INTENDED. THE PATIENT¿S EVENT HISTORY WAS SUBMITTED FOR REVIEW AND CONTAINED APPROXIMATELY 6 HOURS OF DATA WHICH CAPTURED INTERMITTENT POWER ELEVATIONS AS HIGH AS 25.5 WATTS AS WELL AS ¿LOW SPEED/LOW FLOW HAZARD ALARMS, AND PUMP STOPPAGES. THE EVENTS CAPTURED IN THE PATIENT¿S EVENT HISTORY ARE CONSISTENT WITH THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 11 MONTHS POST IMPLANT, IT WAS REPORTED THAT THE PT WAS HOSPITALIZED FOR A HEART TRANSPLANT EVALUATION. WHILE IN THE HOSPITAL, THE PT HAD A PUMP STOPPAGE AND THE PUMP WAS UNABLE TO RESTART. THE SYSTEM CONTROLLER WAS EXCHANGED; HOWEVER, THE PUMP WOULD NOT RESTART. THE PT'S EVENT HISTORY WAS REVIEWED AND INDICATED THAT THE PUMP DID TRY TO RESTART AND THE PUMP POWER WAS ELEVATED. THE PT WAS STABILIZED WITH INOTROPES AND A PUMP EXCHANGE WAS PERFORMED. DURING THE EXCHANGE IT WAS REPORTED THAT THROMBUS WAS SEE WITHIN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591213 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 129938

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention