BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15114635 · Received July 27, 2022

    Report

    Report Number
    2916596-2022-12351
    Event Type
    Death
    Date Received
    July 27, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 27, 2022
    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

    DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (APRIL 2022) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. A ESTRADA-ROMAN, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOLUME 41, ISSUE 4, SUPPLEMENT, 2022, PAGE S78 DEPARTMENT OF MEDICINE, UNIVERSITY OF MINNESOTA, MINNEAPOLIS, MN; MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SPECIFIC INFORMATION REGARDING THE EXPIRED PATIENTS, AS WELL AS HEARTMATE 3 DEVICE SERIAL NUMBERS WERE NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. 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 "INCIDENCE OF BLOOD STREAM INFECTION AND IMPACT ON SURVIVAL IN PATIENTS ON LEFT VENTRICULAR ASSIST DEVICE SUPPORT" IDENTIFYING THAT HM3 MAY BE RELATED TO BLOODSTREAM INFECTION (BSI) AND DEATH. THIS ANALYSIS OF 502 PATIENTS ASSESSED INFECTION INCIDENCES ON PATIENTS WITH CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICES (CF-LVADS) AND IMPACT ON SURVIVAL. SURVIVAL-FREE OF BSI WAS ESTIMATED USING KAPLAN-MEIER METHOD AND COMPARED AMONG DEVICE TYPES. SURVIVAL AMONG PATIENTS WHO DID AND DID NOT DEVELOP BSI BY 9 MONTHS POST IMPLANT WAS COMPARED USING COX REGRESSION ADJUSTING FOR MEDICAL AND SOCIAL FACTORS. PATIENTS IMPLANTED WITH THE HEARTMATE 3 A RATE OF 1-YEAR SURVIVAL FREE OF BSI (87% VS. 95 %, P =0.007). WHEN COMPARING SURVIVAL AFTER 9 MONTHS AMONG THOSE WITH AND WITHOUT BSI, MORTALITY WAS SIGNIFICANTLY HIGHER IN PATIENTS WITH BSI IN BOTH UNADJUSTED (HR =1.96, 95% CI; 1.02 - 3.76) AND ADJUSTED MODELS (2.00, 95% CI; 1.03 - 3.88). BSI CONTINUES TO OCCUR IN THE CONTEMPORARY ERA OF LVAD THERAPY AND IS ASSOCIATED WITH SIGNIFICANTLY WORSE SURVIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944722 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death