BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21411455 · Received February 19, 2025

    Report

    Report Number
    2916596-2025-00981
    Event Type
    Death
    Date Received
    February 19, 2025
    Date of Event
    January 1, 2023
    Report Date
    February 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D4: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE. SMIT, R., ROBINSON, C., MCLEAN, J., DONOVAN, A., DELLA-BOSCA, F., HAYES, H., & LAM, K. (2024). END OF LIFE CARE IN PATIENTS WITH LONG TERM MECHANICAL CIRCULATORY SUPPORT IN WESTERN AUSTRALIA. HEART LUNG AND CIRCULATION, 33, S261. HTTPS://DOI.ORG/10.1016/J.HLC.2024.06.289. (B)(6) HOSPITAL, PERTH, WA, AUSTRALIA. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING STROKE AND DEATH. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. 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 ¿END OF LIFE CARE IN PATIENTS WITH LONG TERM MECHANICAL CIRCULATORY SUPPORT IN WESTERN AUSTRALIA¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH STROKE, HEART FAILURE, DEATH. THE GOAL OF THIS STUDY WAS TO IMPROVE THE PROVISION AND UNDERSTANDING OF END-OF-LIFE CARE (EOLC) FOR LONG TERM MECHANICAL CIRCULATORY SUPPORT (LTMCS). A RETROSPECTIVE OBSERVATIONAL ANALYSIS OF ALL PATIENT DEATHS WITH HEARTMATE 2 (HM2), HEARTMATE 3 (HM3) AND HEARTWARE (HVAD) LMCS IN WESTERN AUSTRALIA FROM 2007 TO 2023 WAS PERFORMED. THE AVERAGE LENGTH OF LTMCS SUPPORT AT TIME OF DEATH WAS 1,115 DAYS (RANGE 3¿4100 DAYS). 65% OF DEATHS HAD .90 DAYS OF SUPPORT AND 60% OF THOSE DEATHS OCCURRED IN A HOSPITAL. 40% OF THE DEATHS WERE CAUSED BY STROKE, AND 20% OF THE DEATHS WERE CAUSED BY HEART FAILURE. 55% OF PATIENTS HAD DOCUMENTED GOALS OF CARE (GOC) AND 35% HAD PALLIATIVE REVIEW. PALLIATIVE CARE INVOLVEMENT WAS CORRELATED WITH LESS INVASIVE INTERVENTIONS. EOLC FOR LTMCS REQUIRES EARLY REFERRAL TO PALLIATIVE CARE. DEATHS WITH PALLIATIVE CARE INVOLVEMENT HAD FEWER MEDICAL INTERVENTIONS, WERE MORE LIKELY TO DIE AT HOME WITH SYMPTOM CONTROL AND MEDICATION TITRATION AND HAD GREATER FAMILY INVOLVEMENT. STRATEGIES TO INCREASE PALLIATIVE CARE SERVICES TO LTMCS PATIENTS MAY LEAD TO IMPROVED QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641512 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death