BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5995694 · Received October 4, 2016

    Report

    Report Number
    2916596-2016-01915
    Event Type
    Death
    Date Received
    October 4, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 9, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INTRAPARENCHYMAL HEMORRHAGE AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE PUMP WAS NOT RETURNED FOR EVALUATION. 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. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 53 DAYS. THERE WERE NO REPORTED DEVICE ISSUES. THE PUMP WAS NOT EXPLANTED AND IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT HAD A LONG, COMPLICATED POST-OPERATIVE COURSE INCLUDING REQUIRING RIGHT VENTRICULAR EXTRACORPOREAL SUPPORT POST-IMPLANT THAT WAS WEANED OFF ON AN UNSPECIFIED DATE. THE PATIENT ALSO REQUIRED INTERMITTENT HEMODIALYSIS. THE PATIENT REPORTEDLY SUFFERED A LARGE RIGHT FRONTAL INTRAPARENCHYMAL HEMORRHAGE AND EXPIRED ON (B)(6) 2016. THE PATIENT'S INR LEADING UP TO THE EVENT WAS 3.9. IT WAS REPORTED THAT THERE WERE NO DEVICE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648855 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death