BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6109009 · Received November 17, 2016

    Report

    Report Number
    2916596-2016-02245
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    October 26, 2016
    Report Date
    May 15, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE: 11 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING AND STROKE 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 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 (LVAD). IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CEREBRAL HEMORRHAGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED FACIAL DROOPING WHILE AT HOME. THE PATIENT BECAME UNRESPONSIVE ON THE WAY TO THE HOSPITAL'S EMERGENCY DEPARTMENT, AND NEVER REGAINED CONSCIOUSNESS. A CT SCAN PERFORMED FOUND 3 PLACES OF CEREBRAL HEMORRHAGING. THE DECISION WAS MADE TO WITHDRAW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760529 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death