BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 5012726 · Received August 19, 2015

    Report

    Report Number
    2916596-2015-01515
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    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

    (B)(4): THE PUMP REMAINS IN THE PATIENT; THE DRIVELINE WAS NOT RETURNED FOR EVALUATION. THE REPORTED DRIVELINE DISCONNECTS, LOW SPEED OPERATIONS, AND MOTOR STOPS WERE CONFIRMED PER THE EVALUATION OF THE SUBMITTED LOG FILES. 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

    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. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRIVELINE DAMAGE AND THE PUMP WAS OFF. THE PATIENT REPORTEDLY HAD SLAMMED THE DRIVELINE IN A DOORWAY AND WIRES APPEARED TO BE DAMAGED UNDER THE SILASTIC AND BIONATE JACKET. THE PATIENT RECEIVED A VISUAL AND AUDIBLE "REPLACE CONTROLLER" ALARM ON THE SYSTEM CONTROLLER. A REVIEW OF THE LOG FILE DATA NOTED MULTIPLE PUMP STOPPAGES AND DRIVELINE DISCONNECTS THAT APPEARED TO HAVE OCCURRED ON BOTH POWER MODULE AND BATTERY POWER. THE DRIVELINE HAD BEEN DISCONNECTED (PUMP OFF) FOR APPROXIMATELY 3.5 HOURS. IT WAS REPORTED THAT THE PATIENT IS INELIGIBLE FOR BOTH TRANSPLANT AND DEVICE EXCHANGE DUE TO NON-COMPLIANCE. THE PATIENT WAS DOING OKAY CLINICALLY AND THE BLOOD PRESSURE WAS WITHIN NORMAL LIMITS. THE PHYSICIAN PRESENTED TWO OPTIONS TO THE PATIENT: 1) SEE HOW THE PATIENT FARES WITHOUT THE PUMP ON, OR 2) RISK TURNING THE PUMP BACK ON VIA SYSTEM CONTROLLER EXCHANGE AFTER IT HAD BEEN OFF FOR SEVERAL HOURS. THE PATIENT ELECTED TO NOT HAVE ANYTHING DONE. THE DRIVELINE WAS CUT AT THE EXIT SITE AND THE PATIENT WAS DISCHARGED HOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO DRIVELINE FRACTURE. FURTHER INFORMATION WAS PROVIDED: THE EVENING OF (B)(6) 2015, THE PATIENT WAS WALKING TO THE STORE AND THE DRIVELINE BECAME CAUGHT IN A DOORWAY AND THE DOOR SLAMMED ONTO HIS DRIVELINE RESULTING IN LVAD ALARMS. IT WAS REPORTED THAT AT 7:07 PM, THE PUMP STOPPED AND SOUNDED WITH DRIVELINE DISCONNECTED ALARMS. THE PATIENT REPORTED CHEST PAIN WITHOUT DYSPNEA. THERE WERE NO FOCAL NEURO DEFICITS. THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL AND WAS THEN TRANSFERRED TO THE IMPLANTING CENTER FOR FURTHER EVALUATION AND MANAGEMENT. THE HOSPITAL STAFF INITIATED HEPARIN AND DOBUTAMINE DRIPS. THE PHYSICIAN DISCUSSED WITH THE PATIENT THE SUSPICION THAT THE PUMP HAD STOPPED DUE TO DRIVELINE FRACTURE. AT THE TIME, A SYSTEM CONTROLLER FAILURE COULD NOT BE EXCLUDED. THE HOSPITAL STAFF WARNED THAT BY SWITCHING OUT THE SYSTEM CONTROLLER AFTER 4 HOURS OF PUMP STOPPAGE THERE WAS RISK OF A POTENTIAL EMBOLIC STROKE. THE PHYSICIAN EXPLAINED TO THE PATIENT THAT HE COULD HAVE A STROKE AND GAVE THE OPTION OF LEAVING THE PUMP OFF. THE PATIENT OPTED TO LEAVE THE PUMP OFF AND IT WAS NEVER RESTARTED. THE LOG FILE WAS REVIEWED AND CONFIRMED THAT THE DRIVELINE WAS FRACTURED AND NOT SUPPLYING POWER TO THE LVAD. THE PATIENT WAS SENT HOME WITH HOSPICE AS HE WAS NOT A CANDIDATE FOR A PUMP EXCHANGE. THE PATIENT EXPIRED ON (B)(6) 2015. THE PUMP WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547848 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| R