BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12071045 · Received June 25, 2021

    Report

    Report Number
    2916596-2021-03109
    Event Type
    Death
    Date Received
    June 25, 2021
    Date of Event
    May 27, 2021
    Report Date
    September 17, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILE CONFIRMED ELEVATIONS IN POWER AND ESTIMATED FLOW ON (B)(6) 2021. A BRIEF LOW FLOW EVENT WAS ALSO OBSERVED ON (B)(6) 2021. A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN THE LOG FILE FINDINGS, REPORTED EVENTS (CARDIAC ARREST, PATIENT OUTCOME) AND HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HMII LVAS), SERIAL NUMBER: (B)(6) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINS UNIQUE DATA FROM ON (B)(6) 2021 AT 09:47:53 THROUGH ON (B)(6) 2021 AT 00:19:30. ONE BRIEF LOW FLOW EVENT WAS CAPTURED ON (B)(6) 2021 AT 03:19:23, IN WHICH ESTIMATED FLOW WAS CAPTURED AT 2.4 LPM. ADDITIONALLY, ELEVATIONS IN POWER AND ESTIMATED FLOW OVER 7.5 W WERE CAPTURED ON (B)(6) 2021 FROM 00:05:27 THROUGH 00:18:34. POWER RANGED FROM 7.7-17.0 W AND ESTIMATED FLOW RANGED FROM 8.4-12.0 LPM FOR THESE EVENTS. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT WHILE THE DRIVELINE WAS CONNECTED. THE CENTER REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC ARREST IN THE FIELD AND WAS NOT ABLE TO BE RESUSCITATED IN THE ER (EMERGENCY ROOM). FLOWS AND POWERS WERE BOTH REPORTED TO EXCEED 10 BEFORE FLOWS DROPPED TO 0 AND CPR (CARDIOPULMONARY RESUSCITATION) WAS STARTED. IT WAS LATER REPORTED THAT NO AUTOPSY RESULTS WERE SHARED. THE CENTER REPORTED THAT HMII LVAS, SERIAL NUMBER: (B)(6) WOULD 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 IMPLANT KIT WAS SHIPPED ON 25AUG2016 VIA CUSTOMER ORDER: (B)(4). THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HMII LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HMII LVAS. SECTION 1 OF THIS IFU PROVIDES AN EXPLANATION OF EACH OF THE PUMP PARAMETERS, INCLUDING POWER AND FLOW. IN REFERENCE TO POWER, THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. IN REFERENCE TO FLOW, THIS SECTION EXPLAINS THAT DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. SECTION 6 "PATIENT CARE AND MANAGEMENT" EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTION 4 OF THIS IFU EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6 EXPLAINS THAT PHYSIOLOGICAL FACTORS THAT AFFECT THE FILLING OF THE PUMP, SUCH AS HYPOVOLEMIA OR POSTURAL HYPOTENSION, RESULT IN REDUCED PUMP FLOWS AS LONG AS THE CONDITION PERSISTS. PUMP FLOWS ARE NOT RESTORED TO NORMAL UNLESS SUCH CONDITIONS ARE TREATED. SECTION 7 OF THIS DOCUMENT CONTAINS INFORMATION ABOUT THE SYSTEM'S ALARMS (INCLUDING LOW FLOW HAZARD ALARMS). NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM SUDDEN CARDIAC ARREST. THIS OCCURRED IN THE FIELD AND THE PATIENT COULD NOT BE RESUSCITATED IN EMERGENCY ROOM. FLOWS AND POWERS WERE BOTH REPORTED TO EXCEED 10 BEFORE FLOWS DROPPED TO 0 LPM AND CARDIOPULMONARY RESUSCITATION WAS STARTED. THE ONLY HISTORY NOTED WAS THE FINAL SHUTTING OFF OF THE CONTROLLER VIA INTERROGATION OF THE BEDSIDE MONITOR. THE LOG FILE CAPTURED SOME INTERMITTENT TRANSIENT LOW FLOW EVENTS ON (B)(6) 2021, (B)(6) 2021, (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021. IT WAS NOTED THAT THERE WERE SOME HIGH POWERS BETWEEN 11-17WATTS ON (B)(6) 2021 AT 0005-0017. THESE EVENTS OCCURRED JUST BEFORE THE DRIVELINE WAS DISCONNECTED AT (B)(6) 2021 AT 0018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961695 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| L