BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6153791 · Received December 8, 2016

    Report

    Report Number
    2916596-2016-02392
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    October 28, 2016
    Report Date
    May 19, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 4 MONTHS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMOLYSIS COULD NOT BE CONCLUSIVELY DETERMINED. HEMOLYSIS 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 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) ON (B)(6) 2016. IT WAS REPORTED THAT DURING A CLINIC VISIT THE PATIENT HAD AN INCREASED LACTATE DEHYDROGENASE (LDH) AND DARK URINE. THE PATIENT¿S INR WAS REPORTED TO BE THERAPEUTIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON HEPARIN. COUMADIN AND ASPIRIN WERE DISCONTINUED. IT WAS REPORTED THAT THERE WERE NO ABNORMAL PUMP PARAMETERS. THE PATIENT WAS STARTED ON INTEGRILIN IN ADDITION TO CONTINUED TREATMENT WITH HEPARIN WHEN THE PATIENT¿S LDH CONTINUED TO INCREASE. IT WAS REPORTED THAT THE PATIENT¿S LDH INCREASED TO 2500 U/L. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED TWICE. ON (B)(6) 2016, IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME UNDER HOSPICE CARE. DESPITE ANTICOAGULATION AND MEDICAL THERAPY, HEMOLYSIS CONTINUED. THE PATIENT¿S LDH CONTINUED TO RISE AND WAS UNMEASURABLE UNDER LABORATORY TESTING. THE PATIENT'S URINE REMAINED DARK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE VAD COORDINATOR ON 04/27/2017 STATED THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE PATIENT'S HEMOLYSIS DID NOT CLEAR WITH TPA ADMINISTRATION AND HEPARIN ADMINISTRATION. THE PATIENT DEVELOPED RENAL FAILURE AND WANTED TO GO HOME WITH HOSPICE. THE PATIENT EXPIRED IN HOME, AND NO AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT PATIENT'S INRS OF 3-3.5 WERE TARGETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804945 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| R