BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 24942581 · Received April 21, 2026

    Report

    Report Number
    2916596-2026-02357
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    April 1, 2025
    Report Date
    April 21, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. HUSAIN, M.S.; LORENTE-ROS, M.; FRANCES, B. SIMON; PRASAD, R.; PINILLA-VERA, M.; ET AL. MEDSTAR WASHINGTON HOSPITAL CENTER, WASHINGTON, DC JOURNAL OF HEART AND LUNG TRANSPLANTATION, SUPPL. SUPPLEMENT 44.4: S44. ELSEVIER INC. (APR 1, 2025). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN 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 RIGHT HEART FAILURE, CARDIAC ARRHYTHMIA, RENAL DYSFUNCTION, AND RESPIRATORY FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS RIGHT HEART FAILURE AND ARRHYTHMIA AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF 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 THROUGH THE RESEARCH ARTICLE TITLED ¿OUTCOMES OF UPFRONT VERSUS RESCUE RVAD PLACEMENT IN HEARTMATE 3 LVAD RECIPIENTS WITH EARLY SEVERE RIGHT VENTRICULAR FAILURE¿ IDENTIFYING THAT HM3 MAY BE RELATED TO DEATH. THIS IS A SINGLE-CENTER RETROSPECTIVE COHORT STUDY, WHICH INCLUDED PATIENTS WHO UNDERWENT HEARTMATE 3 (HM3) LVAD (LEFT VENTRICULAR ASSIST DEVICE) IMPLANT WHO REQUIRED TEMPORARY RVAD (RIGHT VENTRICULAR ASSIST DEVICE) SUPPORT FROM JANUARY 1ST, 2018, TO AUGUST 31ST, 2023. UPFRONT RVAD WAS DEFINED AS RVAD SUPPORT CONCURRENTLY WITH LVAD IMPLANT AND RESCUE RVAD WAS DEFINED AS RVAD THERAPY WITHIN 14 DAYS AFTER RECEIVING LVAD. A TOTAL OF 41 LVAD RECIPIENTS RECEIVED TEMPORARY RVAD SUPPORT FOR EARLY RVF (RIGHT VENTRICULAR FAILURE) DURING THE STUDY PERIOD (21 UPFRONT, 20 RESCUE). THE MEAN AGE WAS 54 YEARS, 30 % FEMALE, AND 71% BLACK PATIENTS. UPFRONT RVAD WAS ASSOCIATED WITH LESS PERIOPERATIVE ATRIAL ARRYTHMIAS, LESS RENAL REPLACEMENT THERAPY NEEDS, AND LOWER IN-HOSPITAL MORTALITY. MULTIVARIABLE ANALYSIS (CONTROLLED FOR AGE AND SEX) DEMONSTRATED A LOWER RISK OF IN-HOSPITAL MORTALITY IN PATIENTS RECEIVING UPFRONT RVAD (HAZARD RATIO, 0.15; 95% CONFIDENCE INTERVAL, 0.03- 0.87). COMPARED TO RESCUE RVAD SUPPORT FOR EARLY SEVERE RVF, UPFRONT RVAD PLACEMENT IN HM3 PATIENTS IS ASSOCIATED WITH BETTER CLINICAL OUTCOMES. PROSPECTIVE STUDIES ARE NEEDED TO DETERMINE LVAD RECIPIENTS AT HIGHER RISK OF RVF WHO MAY BENEFIT FROM AN UPFRONT APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997963 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| L