BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21762117 · Received April 3, 2025

    Report

    Report Number
    2916596-2025-02031
    Event Type
    Death
    Date Received
    April 3, 2025
    Date of Event
    December 12, 2024
    Report Date
    April 3, 2025
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE REPORTED MULTISYSTEM ORGAN FAILURE (MSOF) AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED 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 POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, HEPATIC DYSFUNCTION) AND DEATH, 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 SUFFERED FROM PROGRESSIVE MULTI-ORGAN FAILURE (MOF), AND PASSED AWAY DUE TO MOF. THE MOF WAS NOT CONSIDERED TO BE RELATED TO ANY DEVICE RELATED ISSUE. THE DEVICE WAS RUNNING AS EXPECTED. NO DEVICE ISSUES WERE MENTIONED. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614817 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 7147128 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death