BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11902209 · Received May 28, 2021

    Report

    Report Number
    2916596-2021-02709
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW EVENTS. ALTHOUGH A SPECIFIC CAUSE FOR THE LOW FLOW EVENTS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE CUSTOMER REPORTED THAT THE LOW FLOWS WERE ATTRIBUTED TO ARRYTHMIAS AND RIGHT VENTRICULAR DYSFUNCTION. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED CARDIAC ARRYTHMIA AND RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2021. 148 LOW FLOW CONTROLLER FAULTS WERE CAPTURED WHEN CALCULATED FLOW DROPPED AS LOW AS 1.9 LPM, BELOW THE LOW FLOW THRESHOLD OF 2.5 LPM. OF THESE FAULTS, 85 LASTED AT LEAST 10 SECONDS TO TRIGGER A LOW FLOW ALARM. NO OTHER ABNORMAL ALARMS WERE CAPTURED. THE PUMP OPERATED AT THE INTENDED SPEED AND APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE CONTROLLER PERIODIC LOG FILE CONTAINED DATA FROM (B)(6) 2021. 8 LOW FLOW ALARMS WERE CAPTURED THROUGHOUT THE LOG FILE. NO OTHER ABNORMAL ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE LVAD EVENT AND PERIODIC LOG FILES ALSO CAPTURED THE PUMP OPERATING AS INTENDED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2021. 61 LOW FLOW CONTROLLER FAULTS WERE CAPTURED WHEN CALCULATED FLOW DROPPED AS LOW AS 2.3 LPM, BELOW THE LOW FLOW THRESHOLD OF 2.5 LPM. OF THESE FAULTS, 5 LASTED AT LEAST 10 SECONDS TO TRIGGER A LOW FLOW ALARM. NO OTHER ABNORMAL ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE CONTROLLER PERIODIC LOG FILE CAPTURED 8 LOW FLOW ALARMS THROUGHOUT THE LOG FILE. NO OTHER ABNORMAL ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE LVAD EVENT AND PERIODIC LOG FILES ALSO CAPTURED THE PUMP OPERATING AS INTENDED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2021. 72 LOW FLOW CONTROLLER FAULTS WERE CAPTURED WHEN CALCULATED FLOW DROPPED AS LOW AS 2.1 LPM. OF THESE FAULTS, 8 LASTED AT LEAST 10 SECONDS TO TRIGGER A LOW FLOW ALARM. NO OTHER ABNORMAL FAULTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2021. 21 LOW FLOW CONTROLLER FAULTS WERE CAPTURED WHEN CALCULATED FLOW DROPPED AS LOW AS 2.3 LPM. OF THESE FAULTS, 1 LASTED AT LEAST 10 SECONDS TO TRIGGER A LOG FLOW ALARM. NO OTHER ABNORMAL ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE LOG FILE. THE HEARTMATE 3 LVAS IFU, REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS CARDIAC ARRHYTHMIA AND RIGHT HEART FAILURE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE IFU ALSO STATES ¿RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP.¿ THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM THE MANUFACTURING QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOW FLOW ALARMS WHICH WERE ATTRIBUTED TO ARRHYTHMIAS AND RIGHT VENTRICLE DYSFUNCTION. A RIGHT HEART CATHERIZATION AND ECHOCARDIOGRAM WAS PERFORMED AND PUMP SPEED WAS INCREASED. THE ALARMS RESOLVED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797663 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7845076 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R