BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8104080 · Received November 26, 2018

    Report

    Report Number
    2916596-2018-05208
    Event Type
    Death
    Date Received
    November 26, 2018
    Date of Event
    July 3, 2017
    Report Date
    November 26, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SUBMISSION OF THIS EVENT WAS REPORTED BY THE MANUFACTURER UNDER MFR REPORT # 2916596-2017-01708. THIS REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION. THE REFERENCED THROMBOSED PUMP WAS REPORTED UNDER MEDWATCH MFR REPORT# 2916596-2017-01315. THE EVENT TOOK PLACE AT THE IMPLANTING CENTER, SUTTER HEALTH. APPROXIMATE AGE OF DEVICE - 2 YEARS, 2 MONTHS. DEVICE EVALUATION: THROMBUS WAS CONFIRMED DURING THE EVALUATION OF THE DEVICE. THE PUMP WAS RETURNED WITH THE DRIVELINE CUT APPROXIMATELY 36 INCHES FROM THE PUMP HOUSING AND THE SEVERED PORTION OF DRIVELINE WAS RETURNED. THE SEALED INFLOW CONDUIT WAS RETURNED ATTACHED TO THE PUMP INLET PORT. THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE OUTFLOW ELBOW. THE OUTFLOW BEND RELIEF WAS RETURNED UNATTACHED FROM THE GRAFT ATTACHMENT. AN UNATTACHED BEND RELIEF COLLAR WAS ALSO RETURNED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE LUMEN OF THE INLET TUBE REVEALED DEPOSITIONS OF TISSUE AND BLOOD. EXAMINATION OF THE REMAINING BLOOD-CONTACTING SURFACES REVEALED DEPOSITIONS OF DENATURED BLOOD IN THE LUMENS OF THE INLET ELBOW, OUTFLOW ELBOW, AND THROUGHOUT THE PUMP. THESE DEPOSITIONS WERE HARD, GRAINY, AND STRONGLY ADHERED TO THE PUMP¿S SURFACES. ADDITIONALLY, THE ROTOR WAS DEMAGNETIZED. ALL OF THE DEPOSITIONS APPEARED TO HAVE DEVELOPED AS THE RESULT OF POOR SURFACE WASHING DUE TO A LOW FLOW EVENT OR AN INTERRUPTION IN FLOW THROUGH THE PUMP, CONSISTENT WITH THE REPORT THAT THE PATIENT'S PUMP HAD BEEN OFF FOR AN EXTENDED AMOUNT OF TIME. THESE DEPOSITIONS COULD HAVE CAUSED INCREASED DRAG ON THE ROTOR RESULTING IN AN INCREASE IN TEMPERATURE WITHIN THE PUMP, CONTRIBUTING TO DENATURATION. THIS INCREASE IN TEMPERATURE ALSO COULD HAVE CONTRIBUTED TO THE ROTOR LOSING ITS MAGNETIZATION. A CORRELATION BETWEEN THE FINDINGS OF THE EVALUATION OF THE DEVICE AND THE PATIENT'S PUMP POCKET INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE DEPOSITIONS. UPON REMOVAL OF THE DEPOSITIONS, THE DEVICE WAS CLEANED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND CONNECTED TO A STANDARD H-Q WATER LOOP; HOWEVER, THE PUMP WOULD NOT OPERATE ABOVE 6900 RPM BECAUSE THE ROTOR WAS DEMAGNETIZED. PERMANENT DEGRADATION OF THE MAGNETIC STRENGTH OF THE ROTOR CAN OCCUR IF IT IS EXPOSED TO ELEVATED TEMPERATURES FOR AN EXTENDED PERIOD OF TIME. IN THIS CASE, DUE TO THE INTERRUPTION IN FLOW THROUGH THE PUMP, THE BLOOD INSIDE THE PUMP LIKELY REMAINED STAGNANT AND CONTINUED TO DENATURE AS THE ROTOR SPUN, INCREASING THE RESISTANCE ON THE SPINNING ROTOR AND GENERATING EXCESSIVE HEAT. THROMBUS AND INFECTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. 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 ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR A PUMP POCKET INFECTION. THE IMPLANTED PUMP HAD BEEN TURNED OFF SIX WEEKS PRIOR DUE TO DEVICE THROMBOSIS. THE PUMP HAD BEEN LEFT IN SITU. IT WAS REPORTED THAT INFECTION HAD PROGRESSED TO THE PUMP POCKET AND ENTIRE OUTFLOW GRAFT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2017 TO HAVE THE PUMP AND ALL FOREIGN MATERIAL EXPLANTED. THE PUMP AND OUTFLOW GRAFT WERE REMOVED. THE PUMP POCKET WAS REPORTEDLY COMPLETELY FILLED WITH PUSS AND INFECTED FLUID. POST EXPLANT, THE PATIENT SUFFERED FROM BLEEDING COMPLICATIONS AND A SEVERE INFLAMMATORY RESPONSE AND EXPIRED ON (B)(6) 2017. THE PUMP WAS RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942559 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death