BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3763223 · Received April 16, 2014

    Report

    Report Number
    2916596-2014-00453
    Event Type
    Death
    Date Received
    April 16, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE INTACT. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED DETACHED FROM THE PUMP¿S INLET PORT. THE OUTFLOW GRAFT AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED; HOWEVER, THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. UPON DISASSEMBLY, VISUAL EXAMINATION OF THE PUMP REVEALED TISSUE-LIKE DEPOSITIONS OF BLOOD THROUGHOUT THE DEVICE. THESE DEPOSITIONS WERE NON-LAMINATED AND APPEARED INDICATIVE OF POOR SURFACE WASHING DUE TO A LOW FLOW STATE. THE GRAINY TEXTURE OF THESE DEPOSITIONS SUGGESTS THAT THE EXPLANTED PUMP WAS TREATED WITH A FIXATIVE AGENT BEFORE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT OF A DRIVELINE INFECTION WAS UNABLE TO BE CONFIRMED AND A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THE EVALUATION. UPON REMOVAL OF THE OBSERVED DEPOSITIONS, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. 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 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 MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 7 MONTHS POST-IMPLANT OF (B)(4), A USER FACILITY REPORT WAS SENT TO THE MFR WHICH INDICATED THAT THE PT HAD SIGNS OF THROMBUS WHICH INCLUDED HIGH POWER, HEMOLYSIS AND LOW PL. ON (B)(6) 2014, A PUMP EXCHANGE WAS PLANNED AND THE HOSPITAL DISCONNECTED THE PUMP AND THE PT WAS STABLE. THE HOSPITAL TEAM THEN DECIDED NOT TO EXCHANGE THE PUMP; HOWEVER, THE PT "DECOMPENSATED," CPR WAS INITIATED AND THE PT EXPIRED. IT WAS ALSO REPORTED THAT THROMBUS WAS SEEN ON THE EXPLANTED PUMP. ADDITIONAL INFO OBTAINED FROM THE HOSPITAL INDICATED THAT THE PT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 DUE TO A DRIVELINE INFECTION AND THE FOLLOWING DAY, THE HOSPITAL PERFORMED A OMENTUM-PLASTIC. IN THE WEEK AFTER, THE PT'S PL LEVEL HAD DROPPED, PUMP POWER HAD INCREASED AND THE PT HAD SIGNS OF HEMOLYSIS. ON (B)(6) 2014, AFTER THE PUMP WAS DISCONNECTED THE PT WAS HEMODYNAMICALLY STABLE, MOBILIZED AND HAD GOOD URINE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231636 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 127167

    Patients

    Seq Age Sex Outcome Treatment
    1 Death