BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 17762363 · Received September 17, 2023

    Report

    Report Number
    2916596-2023-06510
    Event Type
    Death
    Date Received
    September 17, 2023
    Date of Event
    August 27, 2023
    Report Date
    November 16, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE PATIENT¿S OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. REVIEW OF THE RETRIEVED LOG FILES CONFIRMED LOW FLOW ALARMS WHICH WERE REPORTEDLY IN THE SETTING OF SEIZURE COMPLICATIONS AND RESUSCITATION EFFORTS. THE CONTROLLER EVENT AND PERIODIC LOG FILES WERE RETRIEVED FROM THE RETURNED CONTROLLER AND REVIEWED. FLOW DECREASED TO 0 LITERS PER MINUTE, ACTIVATING A SUSTAINED LOW FLOW ALARM, IN THE FINAL APPROXIMATELY HOUR OF THE CONTROLLER EVENT LOG FILE. THE PUMP APPEARED TO OPERATE AT THE STORED PATIENT SPEED WITHOUT ISSUE UNTIL THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2023 TO END PUMP SUPPORT. THE SYSTEM APPEARED TO BE OPERATING AS INTENDED, AND THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILES. IT WAS REPORTED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WILL NOT BE RETURNED FOR EVALUATION. 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), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS NEUROLOGIC DYSFUNCTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 1 OF THE IFU PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING SPEED, FLOW, POWER, AND PULSATILITY INDEX (PI). THIS SECTION EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 4 ¿SYSTEM MONITOR¿ PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM (LITERS PER MINUTE) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PASSED AWAY DUE TO COMPLICATIONS FROM SEIZURES. IT WAS UNKNOWN IF THERE WAS ANYTHING GOING ON WITH THE VENTRICULAR ASSIST DEVICE (VAD). THE PATIENT WAS TRANSPORTED FOR SEIZURE ACTIVITY, INTUBATED FOR AIRWAY PROTECTION, SUFFERED CARDIAC ARREST, RESUSCITATION EFFORTS DID NOT PRODUCE RETURN OF SPONTANEOUS CIRCULATION (ROSC) AND VAD HAD ZERO FLOW. THE PATIENT HAD A HISTORY OF SEIZURES PRIOR TO THE LVAD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040315 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 6112855 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death