BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19463051 · Received June 4, 2024

    Report

    Report Number
    2916596-2024-03129
    Event Type
    Death
    Date Received
    June 4, 2024
    Date of Event
    May 6, 2024
    Report Date
    August 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    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 (B)(6), AND THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. G, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (INCLUDING RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, HEPATIC DYSFUNCTION) AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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 HAD HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) AND THROMBOSIS. THE PATIENT'S COMPLETE BLOOD PROFILE (CBP) WAS TAKEN, AND THEIR FLOW DECREASED. RED HEART AND LOW FLOW ALARMS WERE NOTED. THE PATIENT UNDERWENT A PUMP EXCHANGE. INOTROPES WERE INITIATED. THE PATIENT HAD AN EXTRACORPOREAL LIFE SUPPORT (ECLS) THROMBOSIS. AFTER ECLS EXCHANGE THE HEARTMATE 3 FLOW WAS NOT INCREASED ANYMORE. THE PATIENT PASSED AWAY ON (B)(6) 2024 DUE TO MULTIORGAN FAILURE. THE NEW PUMP FUNCTIONED AS EXPECTED. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206999 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 10295718 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death