BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4810144 · Received June 2, 2015

    Report

    Report Number
    2916596-2015-00996
    Event Type
    Death
    Date Received
    June 2, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 4, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 4 YEARS AND 9 MONTHS.THE PUMP IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING, STROKE, PERIPHERAL THROMBOEMBOLISM, RIGHT HEART FAILURE, AND INFECTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF 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. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF AN EMBOLIC STROKE ON AN UNSPECIFIED DATE FOLLOWED BY A HEMORRHAGIC STROKE. THE PATIENT ALSO HAD CHRONIC RIGHT VENTRICULAR FAILURE REQUIRING CONTINUOUS MILRINONE THERAPY. THE PATIENT HAD A MASSIVE INTRACRANIAL BLEED. SUPPORT WAS WITHDRAWN AND THE PATIENT EXPIRED ON (B)(6) 2015. IT WAS REPORTED THAT THE DEVICE WAS FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355130 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death