BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6893215 · Received September 26, 2017

    Report

    Report Number
    2916596-2017-02136
    Event Type
    Death
    Date Received
    September 26, 2017
    Date of Event
    July 31, 2017
    Report Date
    November 30, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S SEX WAS NOT PROVIDED. THE PATIENT¿S WEIGHT WAS NOT PROVIDED. (B)(4). APPROXIMATE AGE OF DEVICE- 2 YEARS AND 8 MONTHS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO DEVICE-RELATED ISSUES WERE IDENTIFIED THROUGH THE EVALUATION OF THE RETURNED PUMP AND A CORRELATION TO THE REPORTED INTRACEREBRAL HEMORRHAGE AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE INTACT. EXAMINATION OF THE SEALED INFLOW CONDUIT AND OUTFLOW CONDUIT UPON DISASSEMBLY OF THE DEVICE REVEALED DEPOSITIONS OF LOOSELY CLOTTED BLOOD. FURTHER EVALUATION OF THE PUMP REVEALED DEPOSITIONS OF LOOSELY CLOTTED AND TISSUE-LIKE CLOTTED BLOOD THROUGHOUT THE PUMP. ALTHOUGH A ROOT CAUSE FOR THE PRESENCE OF THE OBSERVED DEPOSITIONS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT REPORTED THAT THE PATIENT WAS WITHDRAWN FROM SUPPORT AND SUBSEQUENTLY EXPIRED. THE OBSERVED DEPOSITIONS LACKED LAMINATED LAYERING AND STRUCTURE AND WERE LOOSELY SEATED, SUGGESTING THAT THEY RESULTED FROM BLOOD REMAINING WITHIN THE DEVICE POST-EXPLANT. NO ADHERED OR DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS WERE FOUND WITHIN THE RETURNED DEVICE. UPON REMOVAL OF THE DEPOSITIONS, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS 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 FUNCTIONED AS INTENDED. BLEEDING, STROKE AND NEUROLOGIC DYSFUNCTION 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 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

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH ALTERED MENTAL STATUS AND WAS FOUND TO HAVE SPONTANEOUS INTRAVENTRICULAR INTRACRANIAL HEMORRHAGE WITH ACQUIRED HYDROCEPHALUS. UPON ADMISSION, THE PATIENT WAS HYPERTENSIVE 150/100 AND THE INR WAS 3.0. THE PATIENT DETERIORATED NEUROLOGICALLY DUE TO INTRACEREBRAL HEMORRHAGE (ICH), AND THE FAMILY DECIDED TO WITHDRAW CARE. ON (B)(6) 2017, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675159 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death