BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10095713 · Received May 28, 2020

    Report

    Report Number
    2916596-2020-02567
    Event Type
    Death
    Date Received
    May 28, 2020
    Date of Event
    May 8, 2020
    Report Date
    September 28, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: CORRECTION TO MODEL #. SECTION D4: ADDITIONAL INFORMATION TO UDI. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED SEPSIS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE SEPSIS ULTIMATELY LED TO THE PATIENT¿S MULTISYSTEM ORGAN FAILURE (MOF). A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS SEPSIS, AND MULTIPLE TYPES OF ORGAN FAILURES AND DYSFUNCTIONS (HEPATIC DYSFUNCTION, RENAL DYSFUNCTION, RESPIRATORY FAILURE AND RIGHT HEART FAILURE) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. DEATH IS ALSO LISTED AS AN ADVERSE EVENT. CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU. THE HEARTMATE 3 LVAS PATIENT HANDBOOK CONTAINS INFORMATION ABOUT PREVENTING INFECTION. 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 PATIENT EXPIRED DUE TO MOF. THE MOF WAS NOT DEVICE RELATED BUT WAS THE RESULT OF ONGOING SEPSIS AND OTHER UNDERLYING HEALTH ISSUES. THE PATIENT EXPERIENCED SEPSIS, RENAL FAILURE AND DIABETES LEADING UP TO THE PATIENT¿S EXPIRATION. THE DEVICE OPERATED AS EXPECTED AND WAS COMMUNICATED THAT THE PUMP WILL NOT BE RETURNED. THE ACCOUNT COMMUNICATED THAT NEITHER DEATH NOR THE SEPSIS WERE CONSIDERED TO BE DEVICE RELATED. THEY ALSO STATED THAT THEY COULD NOT PROVIDE ANY OTHER INFORMATION.

    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 EXPIRED DUE TO MULTIPLE ORGAN FAILURE (MOF). THE MOF WAS A RESULT OF ONGOING SEPSIS AND FURTHER UNDERLYING HEALTH ISSUES. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560915 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6244850

    Patients

    Seq Age Sex Outcome Treatment
    1 Death