BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 5076662 · Received September 15, 2015

    Report

    Report Number
    2916596-2015-01694
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    July 31, 2015
    Report Date
    August 17, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT WERE NOT SUCCESSFUL. THE PUMP WAS NOT RETURNED FOR EVALUATION. NO PRIOR EVENTS FOR THIS PATIENT WERE REPORTED THROUGHOUT ALMOST TWO YEARS ON LVAD SUPPORT. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED CEREBRAL BLEEDING COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE LISTS BLEEDING AND STROKE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI)# : DEVICE WAS MANUFACTURED PRIOR TO UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE: 1 YEAR AND 11 MONTHS. THE EVENT OCCURRED AT (B)(6) UNIVERSITY (B)(6). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 (LVAD). IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CEREBRAL BLEEDING. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608996 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death