BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15224581 · Received August 15, 2022

    Report

    Report Number
    2916596-2022-12880
    Event Type
    Death
    Date Received
    August 15, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 15, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-025530 AND THE PATIENT'S OUTCOME COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. MLP-025530 WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-025530 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 22APR2021. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. 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 PASSED AWAY. DUE TO PATIENT PRIVACY LAWS THE MANAGING HOSPITAL WOULD NOT COMMUNICATE DETAILS REGARDING THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988656 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7847523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death