BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6172737 · Received December 13, 2016

    Report

    Report Number
    2916596-2016-02429
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    October 3, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ELEVATED LACTATE DEHYDROGENASE (LDH) AND SUSPECTED HEMOLYSIS COULD NOT BE DETERMINED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO SYSTEM CONTROLLER LOG FILES FROM THE TIME OF THE REPORTED EVENT ARE AVAILABLE TO CONFIRM THE REPORTED LOW FLOW ALARMS. DEVICE THROMBOSIS 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 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 ¿ 5 YEARS, 7 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 (LVAD) ON (B)(6) 2011. IT WAS REPORTED THAT ON (B)(6) 2016, THE LVAD SYSTEM PRODUCED LOW FLOW ALARMS, AND THAT THE PATIENT BEEN DECLARED ¿DO NOT RESUSCITATE¿ STATUS. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE OF EXPIRATION WAS REPORTED AS SUSPECTED LVAD THROMBUS, NON-ISCHEMIC CARDIOMYOPATHY (NICM), AND CHRONIC KIDNEY DISEASE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820520 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death