BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 18761615 · Received February 22, 2024

    Report

    Report Number
    2916596-2024-01182
    Event Type
    Death
    Date Received
    February 22, 2024
    Date of Event
    December 1, 2023
    Report Date
    April 4, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A AND D4: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBERS WERE NOT PROVIDED. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (DEC 2023) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE INFORMATION: RAMU, B., COGSWELL, R., RAVICHANDRAN, A. K., CLEVELAND, J., MEHRA, M. R., GOLDSTEIN, D., URIEL, N., DIRCKX, N., AHMED, S., & YUZEFPOLSKAYA, M. (2023). CLINICAL OUTCOMES WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE AMONG WOMEN AND MEN. JACC: HEART FAILURE, 11(12), 1692¿1704. HTTPS://DOI.ORG/10.1016/J.JCHF.2023.08.020. AUTHOR INFORMATION: THE UNIVERSITY OF MINNESOTA, MINNEAPOLIS, MINNESOTA, USA; ASCENSION ST VINCENT, INDIANAPOLIS, INDIANA, USA; UNIVERSITY OF COLORADO SCHOOL OF MEDICINE, AURORA, COLORADO, USA; BRIGHAM AND WOMEN¿S HOSPITAL HEART AND VASCULAR CENTER AND HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA; MONTEFIORE EINSTEIN CENTER FOR HEART AND VASCULAR CARE, NEW YORK, NEW YORK, USA; COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS AND NEW YORK-PRESBYTERIAN HOSPITAL, NEW YORK, NEW YORK, USA; AND ABBOTT INC, ABBOTT PARK, ILLINOIS, USA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) PRODUCTS AND THE REPORTED EVENT OF DEATH COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE, ¿CLINICAL OUTCOMES WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE AMONG MEN AND WOMEN,¿ AUTHORED BY RAMU, ET AL. EXAMINED DIFFERENCES IN CHARACTERISTICS, 2-YEAR OUTCOMES, AND RISK FOR KEY ADVERSE EVENTS AMONG WOMEN AND MEN. THE STUDY FOLLOWED 2,200 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENTS FOR 2 YEARS EACH BETWEEN SEPTEMBER 2014 AND OCTOBER 2020. SURVIVAL AT 2 YEARS WAS CALCULATED AT 82.4% FOR WOMEN AND 80.2% FOR MEN. CAUSE OF DEATH WAS NOT REPORTED, AND IT IS UNKNOWN IF THE OUTCOMES WERE CONSIDERED TO BE DEVICE OR THERAPY RELATED. 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 LVAS INSTRUCTIONS FOR USE (IFU) LISTS DEATH AS A POTENTIAL ADVERSE EVENT 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 THROUGH THE RESEARCH ARTICLE, ¿CLINICAL OUTCOMES WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE AMONG MEN AND WOMEN,¿ THAT WOMEN WHO WERE IMPLANTED WITH A HEARTMATE 3 (HM3) DEVICE HAD INCREASED RATES OF STROKE, MAJOR BLEEDING, AND INFECTION COMPARED TO MEN. THIS MULTI-CENTER STUDY FOLLOWED 2,200 LVAD PATIENTS ENROLLED IN THE MOMENTUM 3 STUDY FOR HM3 AND ANALYZED BOTH MEN AND WOMEN WHO DID NOT SUFFER A DISABLING STROKE, NOR REQUIRE REOPERATION TO REPLACE OR REMOVE A MALFUNCTION PUMP AT 2 YEARS (PRIMARY END POINT). OF THE STUDY POPULATION, 20.4% (448 PATIENTS) WERE WOMEN; THIS POPULATION WAS YOUNGER, WITH NON-ISCHEMIC CARDIOMYOPATHY, AND WERE MORE OFTEN BLACK PERSONS WHEN COMPARED TO MEN. RESULTS SHOWED THE PRIMARY END POINT OR SURVIVAL AT 2 YEARS TO NOT BE SIGNIFICANTLY DIFFERENT BETWEEN WOMEN VERSUS MEN (PRIMARY END POINT: W 79.4% VS. M 75.5% ; SURVIVAL AT 2 YEARS: W 82.4% VS. M 80.2%). RESULTS OF THE STUDIED MAJOR ADVERSE EVENTS, HOWEVER, DID SEE A SIGNIFICANT DIFFERENCE IN RESULTS BETWEEN THE TWO STUDY POPULATIONS. WOMEN WERE MORE LIKELY TO ACQUIRE BLEEDING EVENTS (W 28.1% VS M 23%). THE OCCURRENCE OF MAJOR INFECTIONS, INCLUDING DRIVELINE INFECTIONS, WAS ALSO HIGHER IN WOMEN VERSUS MEN. WOMEN WITH MULTIPLE INFECTIONS WERE MORE LIKELY TO HAVE A HIGHER BODY MASS INDEX (BMI) (31.3 VS. 29.6 KG/M2; P = 0.02. IT WAS ALSO NOTED THAT WOMEN WITH MULTIPLE BLEEDING EVENTS WERE OLDER (61.6 +/- 9.7 VS. 55.6 +/ 13.0; P < 0.0001), MORE LIKELY TO BE IMPLANTED AS DT (84% VS. 65%; P < 0.0008) AND HAVE HISTORIES OF HYPERTENSION (75% VS. 57%; P = 0.0008). FOR EVENTS OF GASTROINTESTINAL BLEEDING (GIB), OLDER AGE, DT, LOWER INTERMACS PROFILE AND NON-WHITE RACE WERE SIGNIFICANT RISK FACTORS FOR BOTH WOMEN AND MEN. FOR THE ADVERSE EVENT OF STROKE, HISTORY OF VENTRICULAR ARRHYTHMIA WAS A SIGNIFICANT RISK FACTOR FOR WOMEN (ARR: 1.84 [95% CI: 1.06-3.19]; P = 0.029), WHEREAS HISTORY OF ISCHEMIC CARDIOMYOPATHY WAS A SIGNIFICANT RISK FACTOR FOR MEN (ARR 1.93 [95% CI: 1.38-2.68]; P = 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATES OF RIGHT VENTRICULAR ASSIST DEVICE (RVAD) OR NEED FOR AORTIC OR MITRAL VALVE SURGERIES DURING INITIAL IMPLANTATION; HOWEVER TRICUSPID VALVE PROCEDURES WERE MORE COMMONLY PERFORMED IN WOMEN. THE MEDIAN INTENSIVE CARE UNIT (ICU) AND INDEX HOSPITALIZATION LENGTH OF STAY WERE 1 AND 2 DAYS LONGER IN WOMEN. BOTH GROUPS, WOMEN AND MEN, SAW IMPROVEMENTS IN QUALITY OF LIFE (QOL) DURING THE FIRST 6 MONTHS FOLLOWING LVAD IMPLANTATION. IT WAS ALSO FOUND THAT OLDER WOMEN WERE LESS LIKELY TO HAVE ISCHEMIC CARDIOMYOPATHY (30% VS. 60%; P < 0.0001), HISTORY OF HYPERTENSION (66% VS. 74%; P = 0.076) BUT WERE MORE LIKELY TO BE ON MINERALOCORTICOID RECEPTOR ANTAGONISTS (MRAS) (43% 33%; P = 0.025) COMPARED WITH MEN. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE ADJUSTED RATE OF ADVERSE EVENTS OBSERVED AMONG OLDER WOMEN VS. MEN. IN CONCLUSION, DESPITE THE HIGHER RATES OF ADVERSE EVENTS AMONG WOMEN, THIS STUDY SHOWS THE OVERALL SURVIVAL AT 2 YEARS IS COMPARABLE WITH MEN. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01180 (PUMP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238704 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death