BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICUALR ASSIST DEVICE

    MDR report key: 4203066 · Received October 23, 2014

    Report

    Report Number
    2916596-2014-01768
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORT OF SUSPECTED THROMBUS WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED PUMP. THE DEVICE WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) CUT APPROXIMATELY 10" FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE DL WAS NOT RETURNED. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) ALONG WITH THE SEALED OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. INFORMATION PROVIDED INDICATED THAT THESE REMAIN IMPLANTED AND ONLY THE PUMP BODY WAS REPLACED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP'S OUTLET PORT. VISUAL EXAMINATION OF THE OUTFLOW ELBOW REVEALED NO EVIDENCE OF THROMBUS FORMATIONS OR DEPOSITIONS. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD TUBE/ROTOR INLET SECTION REVEALED A DENATURED THROMBUS RING ADHERED TO THE INLET SECTION REVEALED A DENATURED THROMBUS RING ADHERED TO THE INLET BEARING BALL AND INLET SECTION OF THE ROTOR. THE RING APPEARED TO FORM IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT IT DEVELOPED OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS OPERATING. THE THROMBUS FOUND IN THE BLOOD TUBE/ROTOR INLET SECTION WOULD HAVE CONTRIBUTED TO THE REPORTED ELEVATED LDH. THE THROMBUS WOULD HAVE ALSO CREATED ADDITIONAL RESISTANCE ON THE SPINNING ROTOR, CONTRIBUTING TO THE ELEVATION IN THE REPORTED PUMP POWERS AND HEMATURIA. 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. 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 MANUFACTURING PROCESS; THE DEVICE FUNCTIONED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: PATIENT HAD ROUTINE FOLLOW UP APPOINTMENT THAT SHOWED INCREASE IN LDH TO 641 WITH PEAK OF 1051. UA WITH BLOOD AND ABNORMAL PUMP PARAMETERS. RAMP STUDY COMPLETED WITH NO CHANGE TO LV SIZE DESPITE SPEED CHANGE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PATIENT PRESENTED WITH HEART FAILURE SYMPTOMS, ELEVATED LDH, INCREASED PUMP POWERS AND HEMATURIA. PATIENT STARTED ON HEPARIN DUE TO SUSPECTED THROMBUS. PATIENT CONTINUED TO HAVE WORSENING CLINICAL SYMPTOMS IN LINE WITH SUSPECTED THROMBUS AND THE PATIENT RETURNED TO THE OPERATING ROOM FOR A PUMP EXCHANGE ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676076 HEARTMATE II LEFT VENTRICUALR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 139458

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention