BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6068105 · Received October 31, 2016

    Report

    Report Number
    2916596-2016-02105
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 4, 2016
    Report Date
    July 18, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED PUMP EXCHANGE WAS ON (B)(6) 2016 AND NEUROLOGICAL EVENT WERE REPORTED UNDER MEDWATCH MFR# 2916596-2016-01482. (B)(4). APPROXIMATE AGE OF DEVICE ¿ 3 MONTHS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH THE REPLACEMENT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 2 INCHES FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE DRIVELINE WAS NOT RETURNED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW), OUTFLOW GRAFT, AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. UPON DISASSEMBLY OF THE RETURNED DEVICE, VISUAL INSPECTION OF THE SMOOTH AND TEXTURED BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR ADHERED THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED AND NO ABNORMALITIES WERE FOUND. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTIONS OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. DEVICE THROMBOSIS AND HEMOLYSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015 AND UNDERWENT A PUMP EXCHANGE ON (B)(6) 2016 DUE TO PUMP THROMBOSIS. ON (B)(6) 2016, THE PATIENT UNDERWENT A SECOND PUMP EXCHANGE FOR SUSPECTED DEVICE THROMBOSIS. WHILE IN THE OPERATING ROOM (OR), THE SURGEON REPORTEDLY NOTED VISIBLE CLOT WITHIN THE DEVICE. PRIOR TO THIS PUMP EXCHANGE, NO ELEVATION IN PUMP POWER WAS NOTED; HOWEVER, THE PATIENT'S LABORATORY TEST RESULTS INDICATED AN ELEVATED LACTATE DEHYDROGENASE LEVEL IN THE UPPER 2000'S U/L. A RAMP ECHOCARDIOGRAM DEMONSTRATED NO CHANGE IN THE LEFT VENTRICLE DIMENSIONS WHEN THE PUMP SPEED WAS INCREASED. ADDITIONALLY, THE PATIENT HAD EXPERIENCED AN ONGOING UNREPORTED PUMP POCKET INFECTION AND A PREVIOUSLY UNREPORTED CEREBROVASCULAR ACCIDENT (CVA). ANTICOAGULATION WAS HELD FOR AN UNSPECIFIED AMOUNT OF TIME. IT WAS REPORTED THAT THIS MAY HAVE CONTRIBUTED TO THE LVAD THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717937 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R