BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4162607 · Received October 7, 2014

    Report

    Report Number
    2916596-2014-01793
    Event Type
    Death
    Date Received
    October 7, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS SHUT OFF AFTER THE EXPIRATION. THERE WILL NOT BE AN AUTOPSY AND THE PUMP WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED AN ISCHEMIC LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE NOTED ON (B)(6) 2014. THE PATIENT WAS EXTUBATED BUT DIALYSIS DEPENDENT AT THE TIME. THE LDH WAS "ABOVE NORMAL LIMITS" PER THE VAD COORDINATOR SINCE TIME OF IMPLANT. IT WAS NOTED THAT THE PATIENT HAD PREOPERATIVE STROKE APPROXIMATELY ONE WEEK PRIOR TO IMPLANT. THE VAD COORDINATOR IS UNSURE OF ETIOLOGY THERE WERE NO FOCAL DEFICITS AT TIME OF IMPLANT. NO ALARMS WERE REPORTED FOR THE EVENT. THE FAMILY DID NOT WISH TO STOP VAD AT THIS TIME WANTED THE DEATH PROCESS TO HAPPEN "NATURALLY". THE PATIENT HAD LABORED BREATHING AND COMFORT CARE WAS INITIATED. THE PATIENT EXPIRED ON (B)(6) 2014. THE CENTER HAD STOPPED TREATMENT AND THE PATIENT EXPIRED THAT EVENING. THE PUMP WAS SHUT OFF AFTER THE EXPIRATION. THERE WILL NOT BE AN AUTOPSY AND THE PUMP WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629995 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 144727

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death