BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6091776 · Received November 9, 2016

    Report

    Report Number
    2916596-2016-02184
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    September 10, 2016
    Report Date
    October 14, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 2 YEARS. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SUBDURAL HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPIRED ON 09/10/2016. THE CAUSE OF EXPIRATION WAS REPORTED AS A SUBDURAL HEMATOMA. THE PATIENT HAD PRESENTED WITH UNSPECIFIED STROKE-LIKE SYMPTOMS, AND WAS FOUND TO HAVE "A BLEED". IT WAS REPORTED THAT THE DEVICE WAS OPERATING AS EXPECTED AND WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741790 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death