BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12887406 · Received November 29, 2021

    Report

    Report Number
    2916596-2021-06654
    Event Type
    Death
    Date Received
    November 29, 2021
    Date of Event
    September 8, 2021
    Report Date
    December 21, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) 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, "INTRODUCTION," LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, "PATIENT CARE AND MANAGEMENT," OUTLINES INDICATIONS OF RIGHT HEART FAILURE AND PROVIDES THE SUGGESTED TREATMENT OPTIONS FOR PATIENTS WITH RIGHT HEART FAILURE. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED RIGHT HEART FAILURE, AS WELL AS PATIENT OUTCOME, COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO AUTOPSY WAS PERFORMED, AND THE DEVICE WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE. ALTHOUGH THE PATIENT'S DEATH WAS NOT CONSIDERED TO THE LEFT VENTRICULAR ASSIST DEVICE (LVAS) RELATED AND THE DEVICE WAS OPERATING AS INTENDED, NO RIGHT HEART FAILURE WAS REPORTED PRIOR THIS EVENT AND THE LVAS CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783151 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6779709

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death| D