BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22420345 · Received July 7, 2025

    Report

    Report Number
    2916596-2025-04235
    Event Type
    Death
    Date Received
    July 7, 2025
    Date of Event
    June 15, 2025
    Report Date
    September 8, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM (B)(6) 2025 THROUGH (B)(6) 2025, PER THE TIMESTAMPS. INTERMITTENT LOW FLOW ALARMS WERE CAPTURED ON (B)(6) 2025, AS WELL AS NUMEROUS LOW FLOW FAULT FLAGS THAT WERE NOT SUSTAINED LONG ENOUGH TO ACTIVATE A LOW FLOW ALARM. ON (B)(6) 2025 AT 09:47:10, THE FLOW DECREASED TO 0 AND REMAINED THERE WITH PERSISTENT LOW FLOW ALARMS UNTIL THE DRIVELINE WAS DISCONNECTED. THE DRIVELINE WAS DISCONNECTED, AND THE CONTROLLER WAS PUT IN SLEEP MODE AT 10:58:13, WHICH IS CONSISTENT WITH THE PATIENT¿S EXPIRATION. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS AND EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FOUND DECEASED ON THE MORNING OF (B)(6) 2025. THE CORONER SUSPECTED THE PATIENT HAD BEEN DECEASED FOR 4 DAYS. THE SYSTEM CONTROLLER WAS STILL ALARMING. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED PERSISTENT LOW FLOW HAZARD ALARMS BETWEEN (B)(6) 2025 AND (B)(6) 2025 UNTIL THE PUMP WAS DISCONNECTED FROM THE SYSTEM CONTROLLER AT 10:58 AM ON (B)(6) 2025. THE PERIODIC LOG CONTAINED A SINGLE LOW FLOW HAZARD RECORDED DURING THE PERIODIC INTERVAL ON (B)(6) 2025 AT 10:14 AM. THERE WERE NO OTHER UNUSUAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18799 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8642188 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death