BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6186996 · Received December 19, 2016

    Report

    Report Number
    2916596-2016-02466
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 22, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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, 10 MONTHS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PUMP WAS RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND REPORTED LOW SPEED EVENT LOW FLOW ALARM AND ANOXIC BRAIN INJURY COULD NOT BE CONCLUSIVELY DETERMINED. THE PUMP WAS RETURNED, ENCAPSULATED IN TISSUE, WITH THE DRIVELINE SEVERED APPROXIMATELY 9.5 INCHES FROM THE PUMP HOUSING. THE REMAINDER OF THE DRIVELINE WAS NOT RETURNED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO ADHERED THROMBUS FORMATIONS OR DEPOSITIONS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE REVEALED NO ABNORMALITIES. THE PUMP UNDERWENT CLEANING, REASSEMBLY, AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT HAD NOT BEEN FEELING WELL. INTERROGATION OF THE SYSTEM CONTROLLER HISTORY REVEALED A LOW SPEED ADVISORY ALARM WITH THE PUMP SPEED DECELERATING TO ABOUT 5400 RPM. THE PATIENT REPORTED NOT FEELING AS WELL SINCE THE LVAD CLINICIANS HAD RECENTLY INCREASED THE LVAD SPEED. THE SUBMITTED LOG FILE WAS REVIEWED BY A REPRESENTATIVE OF THE MANUFACTURER¿S TECHNICAL SERVICES TEAM AND DID NOT REVEAL EVENTS CONSISTENT WITH A DRIVELINE ISSUE. ON (B)(6) 2016, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND THE LVAD SYSTEM PRODUCED LOW FLOW ALARMS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER), AND SHORTLY THEREAFTER STOPPED BREATHING. CHEST COMPRESSIONS WERE INITIATED, AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE CLINICIANS IN THE ER REPORTED THAT THE LVAD HAD STOPPED WORKING. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE IMPLANTING CENTER WHERE IT WAS OBSERVED AND REPORTED THAT THE PUMP HAD NOT STOPPED WORKING. THE PATIENT HAD BEEN ON LVAD AND ECMO SUPPORT CONCURRENTLY FOR ABOUT 24 HOURS, AND ECMO WAS DISCONTINUED ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPIRED SECONDARY TO AN UNRECOVERABLE ANOXIC BRAIN INJURY. IT WAS REPORTED THAT THE CAUSE OF THE ANOXIC BRAIN INJURY WAS UNCLEAR. PRIOR TO PATIENT DEATH, THE LVAD WAS EXPLANTED ON (B)(6) 2016 DURING ORGAN DONATION HARVEST. IT WAS REPORTED THAT AT THE TIME OF DEVICE REMOVAL, NOTHING ODD WAS NOTED, AND THAT THE PUMP FUNCTIONED AS EXPECTED UNTIL EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836816 HEARTMATE II LVAS LET VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death