BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8660235 · Received May 31, 2019

    Report

    Report Number
    2916596-2019-02595
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 6, 2019
    Report Date
    August 8, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011996
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: ALTHOUGH THE EVALUATION OF THE SYSTEM CONTROLLER LOG FILE SUBMITTED UNDER PER-2019-0091357 CONFIRMED THE REPORT OF SPIKES IN POWER AND FLOW, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IN ADDITION, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER VAD-62649, AND THE REPORT OF ELEVATED HEMOLYSIS LABS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE SUBMITTED LOG FILE CAPTURED A TRANSIENT ELEVATION IN POWER AND FLOW ON (B)(6) 2019 AT 10:39:45 AM, REACHING 9.7 W AND 9.2 LPM, RESPECTIVELY. THIS ELEVATION WAS CAPTURED AT THE TIME OF A PI EVENT. DESPITE THIS FINDING, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE DURATION OF THE LOG FILE. THE ACCOUNT COMMUNICATED THAT THE PATIENT HAD BEEN EXPERIENCING SPIKES IN POWER AND FLOW THROUGHOUT (B)(6) 2019 AFTER BEING HOSPITALIZED FOR ELEVATED HEMOLYSIS LABS. THE PATIENT¿S SPEED WAS ADJUSTED FROM 9400 RPM TO 9200 RPM, AND IT WAS NOTED THAT THE PATIENT WAS HYPOTENSIVE WITH A MEAN ARTERIAL PRESSURE OF 30. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE EVENT WERE ISSUED TO THE CUSTOMER; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO THIS DATE. THE INVESTIGATION FILE WILL BE CLOSED ACCORDINGLY. THE PATIENT REMAINS ONGOING ON VAD-62649 AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED. APPROXIMATE AGE OF DEVICE- 1 YEAR, 10 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THE PATIENT HAD INCREASING FLOWS AND POWER SPIKES AFTER THEY WERE HOSPITALIZED FOR ELEVATED HEMOLYSIS LABS. LOG FILE ANALYSIS CONFIRMED THAT POWER AND FLOW ARE TRENDING UPWARDS WITH PI TRENDING DOWNWARDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451178 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 107801 6006294 00813024011996

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization