BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15918542 · Received December 5, 2022

    Report

    Report Number
    2916596-2022-15533
    Event Type
    Death
    Date Received
    December 5, 2022
    Date of Event
    November 14, 2022
    Report Date
    December 5, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MFR NUMBERS #2916596-2022-15405 AND #2916596-2022-15538. MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE PATIENT OUTCOME THAT THE PATIENT PASSED AWAY DUE TO SEPSIS. THE SOURCE OF INFECTION WAS REPORTED TO BE THE DRIVELINE. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE REPORTEDLY OPERATED AS EXPECTED. THE DEVICE WAS NOT EXPLANTED AND WOULD NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045579 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7172162 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| D