BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9432945 · Received December 6, 2019

    Report

    Report Number
    2916596-2019-05560
    Event Type
    Death
    Date Received
    December 6, 2019
    Date of Event
    October 30, 2019
    Report Date
    February 19, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFO. SECTION B2: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS AND PATIENT OUTCOME AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LVAS, SERIAL NUMBER MLP-014027, COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE CURRENT HEARTMATE 3 LVAS IFU LISTS RIGHT HEART FAILURE AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 HAD POST OP RV FAILURE INITIALLY TREATED WITH INOTROPES THEN TREATED WITH TEMPORARY MECHANICAL SUPPORT FOLLOWED BY INFECTION AND MULTISYSTEM ORGAN FAILURE LEADING UP TO DEATH. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED.

    Description of Event or Problem · 0

    DEVICE WILL NOT BE RETURNED FOR EVALUATION; NO AUTOPSY PERFORMED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223625 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6707454 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| L