BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24491817 · Received March 2, 2026

    Report

    Report Number
    2916596-2026-00963
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    January 26, 2026
    Report Date
    April 24, 2026
    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
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF SUSPECTED THROMBUS COULD NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION; HOWEVER, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LEFT VENTRICULAR ASSIST DEVICE (LVAD) INTERNAL FAULT ALARMS AS WELL AS EVENTS CONSISTENT WITH ROTOR INSTABILITY. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED SYSTEM CONTROLLER EVENT LOG FILES CONTAINED RELEVANT EVENTS FROM 26JAN2026. LVAD INTERNAL FAULT ALARMS WERE CAPTURED THROUGHOUT THE DURATION OF THE FILES. SEVERAL SYSTEM CONTROLLER RESETS WERE CAPTURED THROUGHOUT THE FILES, AND THE PUMP ATTEMPTED TO RESTART. THE PUMP BEGAN TO START TWO SEPARATE TIMES; HOWEVER, THE PUMP WAS UNABLE TO RAMP UP TO THE FIXED SPEED BEFORE THE CONTROLLER RESET. OTHERWISE, THE PUMP REMAINED OFF FOR THE REMAINDER OF THE FILES, RESULTING IN LVAD OFF ALARMS. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE EVENTS CAPTURED THROUGHOUT THE FILE APPEAR CONSISTENT WITH ROTOR INSTABILITY. 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 REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING PUMP THROMBOSIS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿HEARTMATE TOUCH COMMUNICATION SYSTEM¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. IT ALSO 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 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. THIS SECTION ALSO LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINES ALL SYSTEM ALARM CONDITIONS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, "HANDLING EMERGENCIES" LISTS EXAMPLES OF EMERGENCIES AND WHAT ACTIONS TO TAKE, INCLUDING WHEN THE PUMP HAS STOPPED. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A4 - PATIENT WEIGHT NOT PROVIDED BY CUSTOMER. 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 PASSED AWAY. LOG FILES WERE PULLED FROM THE PATIENTS SYSTEM CONTROLLERS THAT WERE GIVEN TO THE SITE AFTER THE PATIENT HAD PASSED. THE SITE WAS UNSURE IF THERE WAS ENOUGH DATA ON THE CONTROLLERS TO DETERMINE A CAUSE FOR POTENTIAL PUMP MALFUNCTION. THE PATIENT'S WIFE HAD CALLED THE SITE REPORTING THAT THEY FOUND THE PATIENT SLOUCHED OVER ON A TRACTOR AND THE CONTROLLER WAS READING 0.0 LPM FLOW. THEY PULLED THE PATIENT OFF THE TRACTOR, STARTED CARDIOPULMONARY RESUSCITATION (CPR), AND THEN PERFORMED A CONTROLLER EXCHANGE. ONCE THEY PERFORMED THE CONTROLLER EXCHANGE THERE WAS STILL NO FLOW AND POWER READINGS > 20. WHEN EMERGENCY MEDICAL SERVICES AUTHORITY (EMSA) ARRIVED, THE PATIENT HAD BEEN DOWN FOR OVER 40 MINUTES. TIME OF DEATH WAS CALLED. THE DEATH WAS SUSPECTED TO BE DUE TO THROMBUS THAT EVENTUALLY LED TO PUMP FAILURE AFTER THE PATIENT WAS NOT ON ANTICOAGULATION THERAPY AND UNABLE TO RETURN FLOW WITH THE CONTROLLER EXCHANGE. THE PATIENT'S WIFE NOTED THAT THEY HAD BEEN FEELING FINE AND DID NOT REPORT HAVING ANY SYMPTOMS THAT MORNING. IT WAS NOTED THE PATIENT HAD NOT BEEN ON WARFARIN SINCE 2021 DUE TO SEVERE GASTROINTESTINAL (GI) BLEEDING. (CS-223663). LOG FILES WERE SENT FOR REVIEW. THE PRIMARY CONTROLLER EVENT LOG FILES CONTAINED PUMP OFF, LVAD INTERNAL FAULTS, CIRCUIT OVERTEMPERATURE, AS WELL AS VARIOUS OTHER ALARMS ASSOCIATED WITH A POSSIBLE ROTOR OBSTRUCTION EVENT. THE ACTUAL START OF THIS EVENT WAS UNABLE TO BE SEEN DUE TO THE NUMEROUS ALARMS OVERWRITING THE CONTROLLER MEMORY. THE PERIODIC LOG FILE INDICATED THAT THE PUMP WAS RUNNING NORMALLY DURING THE PRIMARY CONTROLLER'S FINAL PERIODIC RECORDING ON 25JAN26 AT 2:25PM. THE BACKUP CONTROLLER EVENT LOG FILES CONTAINED SIMILAR PUMP OFF, LVAD INTERNAL FAULT, CIRCUIT OVERTEMPERATURE, AS WELL AS VARIOUS OTHER ALARMS. THIS LOG FILE INDICATED THAT THE PUMP DID BRIEFLY RESTART WITH VARIOUS INDICTORS OF A ROTOR OBSTRUCTION ONGOING. THE PUMP WAS UNABLE TO RESUME AND MAINTAIN THE PROGRAMMED SET SPEED. IT WAS COMMUNICATED ON 10FEB2026 THAT THE SITE DID NOT HAVE THE PUMP AS AN AUTOPSY WAS NOT PERFORMED ON THIS PATIENT. BOTH CONTROLLERS WOULD BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. LOG FILES WERE PULLED FROM THE PATIENTS SYSTEM CONTROLLERS THAT WERE GIVEN TO THE SITE AFTER THE PATIENT HAD PASSED. THE SITE WAS UNSURE IF THERE WAS ENOUGH DATA ON THE CONTROLLERS TO DETERMINE A CAUSE FOR POTENTIAL PUMP MALFUNCTION. THE PATIENT'S WIFE HAD CALLED THE SITE REPORTING THAT THEY FOUND THE PATIENT SLOUCHED OVER ON A TRACTOR AND THE CONTROLLER WAS READING 0.0 LPM FLOW. THEY PULLED THE PATIENT OFF THE TRACTOR, STARTED CARDIOPULMONARY RESUSCITATION (CPR), AND THEN PERFORMED A CONTROLLER EXCHANGE. ONCE THEY PERFORMED THE CONTROLLER EXCHANGE THERE WAS STILL NO FLOW AND POWER READINGS > 20. WHEN EMERGENCY MEDICAL SERVICES AUTHORITY (EMSA) ARRIVED, THE PATIENT HAD BEEN DOWN FOR OVER 40 MINUTES. TIME OF DEATH WAS CALLED. THE PATIENT'S WIFE NOTED THAT THEY HAD BEEN FEELING FINE AND DID NOT REPORT HAVING ANY SYMPTOMS THAT MORNING. IT WAS NOTED THE PATIENT HAD NOT BEEN ON WARFARIN SINCE 2021 DUE TO SEVERE GASTROINTESTINAL (GI) BLEEDING. LOG FILES WERE SENT FOR REVIEW. THE PRIMARY CONTROLLER EVENT LOG FILES CONTAINED PUMP OFF, LVAD INTERNAL FAULTS, CIRCUIT OVERTEMPERATURE, AS WELL AS VARIOUS OTHER ALARMS ASSOCIATED WITH A POSSIBLE ROTOR OBSTRUCTION EVENT. THE ACTUAL START OF THIS EVENT WAS UNABLE TO BE SEEN DUE TO THE NUMEROUS ALARMS OVERWRITING THE CONTROLLER MEMORY. THE PERIODIC LOG FILE INDICATED THAT THE PUMP WAS RUNNING NORMALLY DURING THE PRIMARY CONTROLLER'S FINAL PERIODIC RECORDING ON (B)(6) 2026 AT 2:25PM. THE BACKUP CONTROLLER EVENT LOG FILES CONTAINED SIMILAR PUMP OFF, LVAD INTERNAL FAULT, CIRCUIT OVERTEMPERATURE, AS WELL AS VARIOUS OTHER ALARMS. THIS LOG FILE INDICATED THAT THE PUMP DID BRIEFLY RESTART WITH VARIOUS INDICTORS OF A ROTOR OBSTRUCTION ONGOING. THE PUMP WAS UNABLE TO BE RESUME AND MAINTAIN THE PROGRAMMED SET SPEED. IT WAS COMMUNICATED ON (B)(6) 2026 THAT THE SITE DID NOT HAVE THE PUMP AS AN AUTOPSY WAS NOT PERFORMED ON THIS PATIENT. MFR# 2916596-2026-01076 (SEVERE GI BLEEDING IN 2021)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63561 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6153059 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1