BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 23497785 · Received November 7, 2025

    Report

    Report Number
    2916596-2025-07139
    Event Type
    Death
    Date Received
    November 7, 2025
    Date of Event
    October 26, 2025
    Report Date
    November 7, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: ADDITIONAL PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. 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 CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU REV. B IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION AND DEATH, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO MULTI ORGAN FAILURE (MOF). THE OUTCOME WAS NOT CONSIDERED DEVICE RELATED. THE DEVICE WAS NOT EXPLANTED. THE PATIENT DID NOT SUFFER MOF PRE-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177647 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524 L00003504 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death