BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19430797 · Received May 30, 2024

    Report

    Report Number
    2916596-2024-03207
    Event Type
    Death
    Date Received
    May 30, 2024
    Date of Event
    May 27, 2024
    Report Date
    September 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: PATIENT AGE NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED PATIENT OUTCOME AND PROBABLE CLOT MIGRATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM (B)(6) 2024 THROUGH (B)(6) 2024. THE FILE CAPTURED DECREASES IN PUMP FLOW WHICH TRIGGERED LOW FLOW ALARMS ON (B)(6) 2024. ON (B)(6) 2024 A SUSTAINED LOW FLOW ALARM WAS CAPTURED. THE PUMP FLOW DECREASED FROM 2.8 TO 0.0 LITER PER MINUTE (LPM) WHICH CORRESPONDED WITH THE DECREASE IN POWER AND PULSATILITY INDEX (PI) VALUES. THE PUMP STOPPED WHEN THE DRIVELINE WAS DISCONNECTED. THESE EVENTS ARE CONSISTENT WITH THE REPORTED INGEST CLOT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEVICE THROMBUS, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ADDITIONALLY, THIS SECTION ADDRESSES PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR,¿ DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. 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 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. THIS SECTION ALSO LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDE INFORMATION ON SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS BRUTAL LOW FLOW WHERE THE FLOW SHOWED 0 ON THE SCREEN AND PUMP STOP. PUMP SPEED MODIFICATIONS WERE MADE. THE PATIENT PASSED AWAY DUE TO PROBABLE MIGRATION OF A CLOT DURING CHANGE OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR. THE PATIENT'S DEATH WAS CONSIDERED DEVICE RELATED, BUT THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225394 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 10050797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death