BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6070156 · Received November 1, 2016

    Report

    Report Number
    2916596-2016-02115
    Event Type
    Death
    Date Received
    November 1, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 5, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 26 DAYS. THE PUMP WAS RETURNED FOR INVESTIGATION. NO DEVICE-RELATED ISSUES WERE IDENTIFIED DURING THE EVALUATION OF HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND A CORRELATION TO THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE INTACT. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP'S INLET PORT. THE SEALED OUTFLOW CONDUIT (OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND OUTFLOW ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR WAS SECURED IN PLACE AROUND THE OUTFLOW GRAFT NUT. EXAMINATION OF THE PUMP UPON DISASSEMBLY REVEALED DEPOSITIONS OF LOOSELY COAGULATED BLOOD WITHIN THE SEALED INFLOW CONDUIT, THE SEALED OUTFLOW CONDUIT, AND WITHIN THE PUMP. THESE DEPOSITIONS WERE NOT ADHERED AND THE LACK OF STRUCTURE INDICATED THAT THEY FORMED ACUTELY. NO DEVELOPED DEPOSITIONS OR ADHERED THROMBUS FORMATIONS WERE IDENTIFIED. UPON REMOVAL OF THE OBSERVED DEPOSITIONS, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. THE PUMP PASSED ALL FUNCTIONAL TESTING. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT¿S TWO STROKES OCCURRED IN (B)(6) 2016. FIRST STROKE, IN (B)(6) 2016, WAS EMBOLIC. THE PATIENT PRESENTED WITH WEAKNESS ON ONE SIDE, SLURRED SPEECH, DYSPLASIA, AND CUT VISION. THE PATIENT WAS TO HAVE RECOVERED FROM ALL SYMPTOMS. THE STROKE IN (B)(6) 2016 WAS HEMORRHAGIC. THE PATIENT NEVER RECOVERED FROM STROKE SYMPTOMS AND HAD TO BE INTUBATED. TREATMENT PROVIDED TO THE PATIENT FOR IN RESPONSE TO BOTH STROKES WAS REQUESTED, BUT NOT PROVIDED. IT WAS REPORTED THAT AT THE DEVICE WAS OPERATING AS EXPECTED. ALL PARAMETERS WERE WITHIN NORMAL RANGES.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT EXPIRED FROM UNKNOWN CAUSES. IT WAS REPORTED THAT THE PATIENT HAD TWO PREVIOUSLY UNREPORTED STROKES PRIOR TO EXPIRATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720277 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death