BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 20465637 · Received October 16, 2024

    Report

    Report Number
    2916596-2024-06566
    Event Type
    Death
    Date Received
    October 16, 2024
    Date of Event
    September 17, 2024
    Report Date
    November 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    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

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED, AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) WAS NOT EXPLANTED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION B IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (INCLUDING RIGHT HEART, RESPIRATORY, RENAL, AND HEPATIC FAILURE), AND DEATH 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 PASSED AWAY DUE TO MULTIORGAN FAILURE (MOF). NO DEVICE RELATED ISSUE LED TO THE MOF WHICH WAS RELATED TO THE OUTCOME. THE ORGANS DIDN'T RECOVER BUT MOF WAS PROGRESSIVE AND COULD NOT BE TREATED ANYMORE. THE DEVICE WAS RUNNING AS EXPECTED. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. AN AUTOPSY WOULD NOT BE PERFORMED, AND THE PUMP WOULD NOT BE EXPLANTED OR RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049205 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6060404 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death