BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3192732 · Received June 25, 2013

    Report

    Report Number
    2916596-2013-00808
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND EVALUATED. THE DEVICE WAS ASSEMBLED WITH THE PERCUTANEOUS LEAD CUT APPROXIMATELY 2" FROM THE PUMP HOUSING; THE SEVERED PORTION OF THE LEAD WAS RETURNED. THE INFLOW CONDUIT, OUTFLOW GRAFT, AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. THE OUTLET ELBOW WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. VISUAL EXAMINATION OF THE PROXIMAL SIDE OF THE INLET STATOR AND THE DISTAL SIDE OF THE OUTLET STATOR PRIOR TO DISASSEMBLY REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. EXAMINATION OF THE DEVICE UPON DISASSEMBLY REVEALED A THROMBUS FORMATION SURROUNDING THE BEARING BALL OF THE ROTOR. ITS LAMINATED STRUCTURE AND AREAS OF DENATURATION INDICATE THAT THIS THROMBUS LIKELY FORMED OVER AN UNDETERMINED PERIOD OF TIME WHILE THE DEVICE WAS SUPPORTING THE PATIENT. ALTHOUGH THE EVALUATION COULD NOT CONCLUSIVELY DETERMINE A CAUSE FOR THE DEVELOPMENT OF THE OBSERVED THROMBUS, THE FORMATION COULD HAVE CONTRIBUTED TO THE REPORTED EVALUATIONS IN LDH AND FREE HEMOGLOBIN. EXAMINATION OF THE DISASSEMBLED PUMP ALSO REVEALED A NON-LAMINATED DEPOSITION IN THE OUTLET STATOR SURROUNDING THE BEARING BALL. THE DEPOSITION DID NOT SHOW ANY LAMINATED LAYERING, INDICATING THAT IT DID NOT FORM IN THE OUTLET STATOR. ADDITIONALLY, THE DEPOSITION WAS LOOSE AND FREE OF DENATURATION, SUGGESTING THAT IT DEVELOPED ACUTELY WHILE THE DEVICE WAS SUPPORTING THE PATIENT. ALTHOUGH THE ORIGIN OF THIS DEPOSITION AND THE CAUSE FOR ITS DEVELOPMENT COULD NOT BE DETERMINED THROUGH THIS EVALUATION, IT COULD HAVE CONTRIBUTED TO THE REPORTED ELEVATIONS IN LDH AND FREE HEMOGLOBIN. THROMBUS FORMATION IS COMPLEX AND MULTI-FACTORIAL IN NATURE AND NOT NECESSARILY RELATED TO A SINGLE PHYSIOLOGICAL OR DEVICE-RELATED FACTOR. THE DISASSEMBLED PUMP'S BEARING ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. 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 AND THE DEVICE FUNCTIONS AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH SIGNS OF GROSS HEMATURIA DUE TO SUSPECTED PUMP THROMBUS. THE PATIENTS LDH, FREE HGB AND CREATININE WAS ELEVATED. AFTER SEVERAL DAYS ON HEPARIN DRIP AND MONITORING, THE PATIENT SHOWED NO SIGNS OF IMPROVEMENT. THE DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287890 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124412

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention