BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4142721 · Received October 2, 2014

    Report

    Report Number
    2916596-2014-01697
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND NO DEVICE-RELATED ISSUES WERE DISCOVERED DURING THE EVAL. THE DEVICE WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD (LEAD) CUT APPROX 4 INCHES FROM THE PUMP HOUSING AND THE REMAINDER OF THE LEAD WAS NOT RETURNED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RECEIVED ATTACHED TO THE PUMP'S INLET PORT. THE OUTFLOW CONDUIT (OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND OUTFLOW ELBOW) WAS RETURNED ATTACHED TO THE PUMP'S OUTLET PORT. PRIOR TO DISASSEMBLY, VISUAL EXAMINATION OF THE INFLOW CONDUIT AND THE OUTFLOW CONDUIT REVEALED NO EVIDENCE OF THROMBUS FORMATIONS OR DEPOSITIONS. EVAL OF THE PUMP UPON DISASSEMBLY REVEALED NO EVIDENCE OF THROMBUS FORMATIONS OR DEPOSITIONS. THE PUMP BEARINGS ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. ELECTRICAL CONTINUITY TESTING DID NOT REVEAL AN DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, 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 MFG PROCESS, AND THE DEVICE FUNCTIONED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS ROUTINELY TRANSPLANTED BUT HAS HAD ELEVATED LACTATE DEHYDROGENASE (LDH) IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614849 HEARTMATE II LVAS DSQ THORATEC CORP. 104911 112487

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention