BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4904591 · Received July 9, 2015

    Report

    Report Number
    2916596-2015-01250
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 11, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL EVALUATION OF THE DEVICE COULD NOT BE CONDUCTED BECAUSE IT WAS NOT RETURNED BY THE HOSPITAL. A CORRELATION BETWEEN THE DEVICE AND THE PATIENT'S INTRACRANIAL HEMORRHAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS BLEEDING, STROKE AND DEATH AS A 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 THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 9 MONTHS.NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO AN INTRACRANIAL HEMORRHAGE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445038 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death