BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16372453 · Received February 14, 2023

    Report

    Report Number
    2916596-2023-00943
    Event Type
    Death
    Date Received
    February 14, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 14, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(4) AND THE PATIENT'S OUTCOME COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2023, AND THE CAUSE OF DEATH WAS NOT PROVIDED. DUE TO PATIENT PRIVACY LAWS THE MANAGING HOSPITAL WOULD NOT COMMUNICATE ADDITIONAL PATIENT OUTCOME INFORMATION. IT WAS REPORTED THAT AN AUTOPSY WAS NOT CONDUCTED AND THAT HM3 LVAS, SERIAL NUMBER (B)(4), WAS NOT EXPLANTED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-031339 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH THAT MAY BE ASSOCIATED WITH THE USE OF 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 PASSED AWAY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964200 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 8387154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death