BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT

    MDR report key: 9777209 · Received March 2, 2020

    Report

    Report Number
    2916596-2020-01161
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 2, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024010616
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN DEVICE AND THE REPORTED RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE IFU CAUTIONS: ¿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.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT HEART FAILURE WAS NOT DEVICE RELATED.

    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 WAS PRESENTING SIGNS AND SYMPTOMS OF WORSENED RIGHT HEART FAILURE AND POSSIBLE FLUID OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237141 HEARTMATE II LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103695 813024010616

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other