BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6101332 · Received November 15, 2016

    Report

    Report Number
    2916596-2016-02224
    Event Type
    Death
    Date Received
    November 15, 2016
    Date of Event
    May 14, 2016
    Report Date
    October 26, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE AND BLEEDING 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 NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE  2 YEARS AND 4 MONTHS. THE EVENT OCCURRED IN THE (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). ON (B)(6) 2016, APPROXIMATELY 2 YEARS AND 4 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE AND LOST CONSCIOUSNESS. THE PATIENTS INR VALUE WAS 2.5. A DECISION WAS MADE TO TREAT THE PATIENT CONSERVATIVELY. THE PUMP WAS STOPPED MANUALLY ON (B)(6) 2016, AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752442 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death