BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19035743 · Received April 3, 2024

    Report

    Report Number
    2916596-2024-01647
    Event Type
    Death
    Date Received
    April 3, 2024
    Date of Event
    March 14, 2024
    Report Date
    July 8, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D4, CATALOG NUMBER: CORRECTED. SECTION H6: CODES CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DRIVELINE DISCONNECT EVENT WAS CONFIRMED VIA THE SUBMITTED LOG FILES. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS (LEFT VENTRICULAR ASSIST SYSTEM), SERIAL NUMBER (B)(6), AND THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS ON SPANNING FROM (B)(6) 2024. ON (B)(6) 2024 AT 06:06:18 THE DRIVELINE WAS DISCONNECTED FROM THE SYSTEM CONTROLLER, RESULTING IN DRIVELINE DISCONNECT/ASSOCIATED ALARMS BECOMING ACTIVE AND ALL PUMP-RELATED PARAMETERS CHANGING TO 0. THE DRIVELINE WAS RECONNECTED TO THE SYSTEM CONTROLLER APPROXIMATELY 22 MINUTES LATER, AND THE PUMP RAMPED BACK UP TO THE SET SPEED. THROUGHOUT THE LOG FILE, THE PUMP APPEARED TO HAVE BEEN OPERATING AS INTENDED WHILE THE DRIVELINE WAS CONNECTED TO THE SYSTEM CONTROLLER. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 2-11: IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION. SECTION 7 OUTLINES ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING INFORMATION: SECTIONS 2 AND 4: CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED INTO THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP. SECTION 2: THE PUMP WILL STOP IF THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESTART THE PUMP. THE PUMP CANNOT RUN WITHOUT POWER. SECTION 5 OUTLINES ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST CONSCIOUSNESS DUE TO A PUMP STOP. THE CAUSE OF THE PUMP STOP WAS DRIVELINE DISCONNECTION. THE CONTROLLER WAS EXCHANGED; THE PATIENT WAS TAKEN TO THE HOSPITAL BY AN EMERGENCY TEAM AND WAS INTUBATED WITH INOTROPES. CARDIAC ECHOCARDIOGRAM DID NOT SHOW ANY PROBLEM TO THE PATIENT. THE PUMP WAS NOT WORKING FOR 24 MINUTES UNTIL IT WAS RESTARTED. IT WAS NOTED THAT THE CONTROLLER EXCHANGE WAS NOT WHAT RESTARTED THE PUMP. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY DUE TO CEREBRAL ANOXIA. WHETHER THE DEATH WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED. AN AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447343 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7948035 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death