BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5009502 · Received August 18, 2015

    Report

    Report Number
    2916596-2015-01509
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 21, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 1 YEAR, 9 MONTHS. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED CEREBRAL HEMORRHAGE COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING AND STROKE ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT 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 (LVAD). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO A RIGHT CEREBRAL INTRAPARENCHYMAL HEMORRHAGE. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT SWEATY, WEAK, DISORIENTED AND WITH LEFT SIDED WEAKNESS. A HEAD CT SCAN REVEALED A HEAD BLEED WHICH WAS UNABLE TO BE CONTROLLED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO ATTEMPT TO CONTROL THE BLEEDING; HOWEVER THE BLEEDING COULD NOT BE CONTROLLED. THE PATIENT WAS ADMITTED TO THE ICU WHERE THE PATIENT'S FAMILY MADE A DECISION TO WITHDRAW CARE. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY HISTORY THAT WOULD HAVE BEEN RELEVANT TO THE EVENT. THE PATIENT'S INR GOAL WAS 2.8 AND HAD BEEN THERAPEUTIC MONTHS PRIOR. UPON ADMISSION THE INR WAS 1.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545760 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death