BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24179123 · Received January 26, 2026

    Report

    Report Number
    2916596-2026-00510
    Event Type
    Death
    Date Received
    January 26, 2026
    Date of Event
    May 23, 2024
    Report Date
    January 26, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN FEBRUARY 2018 THROUGH MAY 2024. AUTHOR INFORMATION: EAST, L., JOLY, J., NICELY, P., KUKUC, L., WILSON, M., BLOOD, M., BAKER, E., JUAREZ, L., TALLAJ, J., HOLMAN, W., LOHR, N., HALL, Y., & CLARKSON, S. (2026). IMPACT OF ADVERSE SOCIAL DETERMINANTS ON QUALITY OF LIFE AND SATISFACTION AFTER LEFT VENTRICULAR ASSIST DEVICE: A SOUTHERN SINGLE-CENTER PILOT EXPERIENCE. HEART & LUNG, 75, 321¿328. HTTPS://DOI.ORG/10.1016/J.HRTLNG.2025.10.024. CORRESPONDING AUTHOR AT: TINSLEY HARRISON TOWER, SUITE 311, 1900 UNIVERSITY BOULEVARD, BIRMINGHAM, AL 35233. E-MAIL ADDRESSES: [email protected] (L. EAST), [email protected] (J. JOLY), [email protected] (P. NICELY), [email protected] (L. KUKUC), MARIEWILSON@ UABMC.EDU (M. WILSON), [email protected] (M. BLOOD), [email protected] (E. BAKER), [email protected] (L. JUAREZ), [email protected] (J. TALLAJ), [email protected] (W. HOLMAN), [email protected] (N. LOHR), [email protected] (Y. HALL), [email protected] (S. CLARKSON). DIVISION OF CARDIOVASCULAR DISEASE, UNIVERSITY OF ALABAMA AT BIRMINGHAM, TINSLEY HARRISON TOWER, SUITE 311, 1900 UNIVERSITY BOULEVARD, BIRMINGHAM, AL 35233, USA; DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF ALABAMA AT BIRMINGHAM, BOSHELL DIABETES BUILDING, SUITE 477, 1720 2ND AVE SOUTH BIRMINGHAM, AL 35294, USA; DEPARTMENT OF SOCIOLOGY, UNIVERSITY OF ALABAMA AT BIRMINGHAM, HERITAGE HALL 460, 1401 UNIVERSITY BOULEVARD, BIRMINGHAM, AL 35233, USA; DIVISION OF GENERAL INTERNAL MEDICINE AND POPULATION SCIENCE, UNIVERSITY OF ALABAMA AT BIRMINGHAM, 621 MEDICAL TOWERS, BIRMINGHAM, AL 35294, USA; DIVISION OF CARDIOTHORACIC SURGERY, UNIVERSITY OF ALABAMA AT BIRMINGHAM, TINSLEY HARRISON TOWER, SUITE 760, 1900 UNIVERSITY BOULEVARD, BIRMINGHAM, AL 35233, USA. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, REV. D IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING 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 IN ¿IMPACT OF ADVERSE SOCIAL DETERMINANTS ON QUALITY OF LIFE AND SATISFACTION AFTER LEFT VENTRICULAR ASSIST DEVICE: A SOUTHERN SINGLE-CENTER PILOT EXPERIENCE¿ THAT THE HEARTMATE 3 (HM3) WAS INVOLVED IN PATIENT DEATH AND HEART TRANSPLANTS (HTX). THE RETROSPECTIVE STUDY EXAMINED THE IMPACTS OF LVAD ON SOCIAL DETERMINANTS OF HEATH (SDOH) AND HEALTH-RELATED QUALITY OF LIFE (HRQOL). A TOTAL OF 111 HM3 PATIENTS WITH IMPLANT DATES BETWEEN WERE 2/19/2018 THROUGH 5/23/2024 WERE INCLUDED IN THE STUDY. IMPACT OF ADVERSE SDOH ON HRQOL AND SELF-REPORTED SATISFACTION WITH LVAD WAS EVALUATED USING LINEAR MIXED MODELS AT 6 MONTHS, 1 YEAR, 1.5 YEARS, AND 2 YEARS, WITH FOLLOW UP DATA AVAILABLE THROUGH MAY 2024. DURING THE TWO-YEAR FOLLOW-UP PERIOD, 13 PATIENTS DIED (22 %) AND 8 PATIENTS WERE TRANSPLANTED (14 %).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240138 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death