BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11023155 · Received December 16, 2020

    Report

    Report Number
    2916596-2020-05922
    Event Type
    Death
    Date Received
    December 16, 2020
    Date of Event
    November 23, 2020
    Report Date
    December 16, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN MLP-013747 AND THE REPORTED HEMORRHAGIC STROKE, AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINED DATA FROM 17NOV2020 TO 23NOV2020. THE PUMP OPERATED AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE FILE. THERE WAS A CAPTURED LOW FLOW EVENT ON 23NOV2020 WHEN THE ESTIMATED FLOW DECREASED BELOW THE 2.5 LITERS PER MINUTE (LPM) ALARM THRESHOLD FOR APPROXIMATELY 10 MINUTES. THIS LOW FLOW EVENT THAT OCCURRED ALSO SHOWED A DECREASE IN MOTOR POWER FROM TYPICAL RANGES. THERE WERE NO FURTHER LOW FLOW ALARMS THROUGHOUT THE REMAINING FILE. THE LOG FILE APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. STROKE, BLEEDING, AND DEATH ARE LISTED AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INTERNATIONAL NORMALIZED RATIO VALUES. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) ALSO DESCRIBES PUMP FLOW. THE SYSTEM MONITOR SECTION DESCRIBES THE PUMP FLOW DISPLAY (4-12 THROUGH 4-14) AND THE HAZARD ALARMS (4-18 AND 4-26). THIS IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM (7-7 AND 7-11). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO HEMORRHAGIC STROKE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM VIA AMBULANCE AND WAS UNRESPONSIVE. A COMPUTED TOMOGRAPHY SCAN REVEALED SIGNIFICANT INTRACRANIAL HEMORRHAGE. TECHNICAL SERVICES REVIEWED THE LOG FILES AND FOUND ROUTINE EVENTS UNTIL 23NOV2020 AT 07:53:54, WHEN THERE WAS A DECREASE IN POWER AND FLOW WITH PULSATILITY INDEX (PI) INCREASING. THIS WAS FOLLOWED BY A BRIEF PERIOD OF RECOVERY IN POWER AND FLOW, THEN ANOTHER DECREASE IN POWER AND FLOW. BY THE END OF THE LOG FILE, PUMP PARAMETERS WERE RETURNING TO THE RANGES SEEN PRIOR TO 23NOV2020 AT 07:53:54. THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE STROKE. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED, AND IT OPERATED AS INTENDED. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487809 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7068517 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death| H