BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21988405 · Received May 8, 2025

    Report

    Report Number
    2916596-2025-02794
    Event Type
    Death
    Date Received
    May 8, 2025
    Date of Event
    January 1, 2016
    Report Date
    August 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    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 B3: THE DATE OF THE EVENT HAS BEEN ENTERED AS 01JAN2016 AS PATIENTS WERE IMPLANTED BETWEEN 2011 AND 2016. NATIONAL LABORATORY ASTANA, NAZARBAYEV UNIVERSITY, ASTANA 010000, KAZAKHSTAN; EURASIAN SOCIETY OF PERSONALIZE MEDICINE, ASTANA 010000, KAZAKHSTAN; DEPARTMENT OF MEDICINE, SEMEY MEDICAL UNIVERSITY, PAVLODAR BRANCH, PAVLODAR 140000, KAZAKHSTAN; DEPARTMENT OF MEDICINE, SEMEY MEDICAL UNIVERSITY, SEMEY 071400, KAZAKHSTAN; SERGIEVSKY CENTER, TAUB INSTITUTE, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY 10032, USA; NATIONAL RESEARCH CARDIAC SURGERY CENTER, ASTANA 010000, KAZAKHSTAN; DEPARTMENT OF GENERAL BIOLOGY AND GENOMICS, L. N. GUMILYOV EURASIAN NATIONAL UNIVERSITY ZHALBINOVA, M.R.; RAKHIMOVA, S.E.; KOZHAMKULOV, U.A.; AKILZHANOV, K.R.; SHAIMARDANOV, N.K.; AKILZHANOVA, G.A.; LEE, J.H.; PYA, Y.V.; BEKBOSSYNOVA, M.S.; AKILZHANOVA, A.R. THE IMPACT OF GENETIC POLYMORPHISM ON COMPLICATION DEVELOPMENT IN HEART FAILURE PATIENTS. J. CLIN. MED. 2025, 14, 35. HTTPS://DOI.ORG/10.3390/JCM14010035 NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION E1: CUSTOMER SITE WAS (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. 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 IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS THE 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, "THE IMPACT OF GENETIC POLYMORPHISM ON COMPLICATION DEVELOPMENT IN HEART FAILURE PATIENT", THAT THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE ASSOCIATED WITH COMPLICATIONS SUCH AS: DEATH, THROMBOSIS, BLEEDING, INFECTIONS, STROKES, AND MYOCARDIAL INFARCTIONS. THE RETROSPECTIVE STUDY AIMED TO CHARACTERIZE THE INFLUENCE OF THE GENETIC POLYMORPHISMS IN THE UGT1A6 GENE ON COMPLICATIONS IN HEART FAILURE (HF) PATIENTS UNDER ANTIPLATELET THERAPY WITH IMPLANTED LVADS. THERE WERE 100 HEART FAILURE PATIENTS RECRUITED FOR THE STUDY, WHICH WERE IMPLANTED WITH LVADS BETWEEN 2011 AND 2016. PATIENTS WERE DIAGNOSED WITH ISCHEMIC CARDIOMYOPATHY (ICM), DILATED CARDIOMYOPATHY (DCM), HYPERTROPHIC CARDIOMYOPATHY (HCM), AND VALVULAR HEART DISEASE (VHD) PRIOR TO IMPLANTATION. THREE TYPES OF LVADS WERE IMPLANTED IN THE PATIENTS FROM THIS STUDY: 18 PATIENTS WITH THE HEARTWARE HVAD, 34 PATIENTS WITH THE HEARTMATE II (HM II), AND 46 PATIENTS WITH THE HEARTMATE 3 (HM3). 2 PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO BEING UNDER 18 YEARS OF AGE. VENOUS BLOOD SAMPLES COLLECTED IN STERILE VACUTAINERS WITH K2EDTA WERE USED TO PERFORM GENETIC ANALYSIS. 41 OF THE HM3 PATIENTS DID NOT EXPERIENCE ANY COMPLICATIONS, WHEREAS 5 OF THE HM3 PATIENTS DID EXPERIENCE COMPLICATIONS (12 HM II PATIENTS AND 7 HVAD PATIENTS EXPERIENCED COMPLICATIONS). OF THE 71 PATIENTS WHO SURVIVED, 13 EXPERIENCED COMPLICATIONS. OF THE 27 PATIENTS WHO PASSED AWAY, 11 EXPERIENCED COMPLICATIONS. THERE WERE 13 PATIENTS (54.2%, P=0.0001) THAT EXPERIENCED THROMBOSIS COMPLICATIONS, 14 PATIENTS (58.3%, P=0.0001) THAT EXPERIENCED BLEEDING COMPLICATIONS, 15 PATIENTS (62.5%, P=0.015) THAT EXPERIENCED INFECTIONS, 8 PATIENTS THAT EXPERIENCED HEMORRHAGIC STROKES, 12 PATIENTS THAT EXPERIENCED ISCHEMIC STROKES, AND 44 PATIENTS THAT EXPERIENCED MYOCARDIAL INFARCTIONS. THE MEAN DURATION OF LVAD SUPPORT WAS 29.6 ± 17.3 MONTHS IN THE STUDY PERIOD (2011¿2016). 71 (72.4%) PATIENTS REACHED THE OUTCOME MEASUREMENT TIME, WHEREAS 27 (27.6%) PATIENTS DID NOT REACH THE OUTCOME MEASUREMENT. 10 (10.2%) PATIENTS WHO REACHED THE OUTCOME MEASUREMENT TIME HAD HEART TRANSPLANTATION (BTT). PATIENTS WERE PRESCRIBED WARFARIN AND ASPIRIN ANTITHROMBOTIC THERAPY FOR THE LONG TERM AFTER DEVICE IMPLANTATION. THE DOSE OF WARFARIN (2.99 ± 1.15 MG/DAY) WAS CORRECTED TO MAINTAIN THE TARGET INTERNATIONAL NORMALIZED RATIO RANGE (INR 2.25¿3.25). THE DAILY DOSE OF ASPIRIN (100 MG/DAY) WAS PRESCRIBED FOR HF PATIENTS ACCORDING TO THEIR MEDICAL INDICATION AND RANGED MONTHLY IN DYNAMICS (BEFORE 14 DAYS, AS WELL AS AFTER 1, 3, 6, 12, AND 18 MONTHS), UNLESS THERE WAS A CONTRAINDICATION, SUCH AS ULCERATIVE GASTRITIS OR LIVER CIRRHOSIS. ON THE 6TH MONTH, 49 PATIENTS (66.2%) WERE NOT RECEIVING ASPIRIN TREATMENT IN THE GROUP OF PATIENTS WITHOUT COMPLICATIONS, WHEREAS 15 PATIENTS (62.5%) WERE RECEIVING ASPIRIN TREATMENT IN THE GROUP OF PATIENTS WITH COMPLICATIONS (P = 0.02). IT WAS DETERMINED THAT POLYMORPHISMS RS9934438 AND RS9923231 IN THE VKORC1 GENE, RS5918 IN THEITGB3 GENE, AND RS2070959 IN THEUGT1A6 GENE WERE SIGNIFICANTLY ASSOCIATED WITH COMPLICATIONS OF HF PATIENTS ACCORDING TO THE LOGISTIC REGRESSION ANALYSIS. POLYMORPHISM RS2070959 IN THE UGT1A6 GENE IS SIGNIFICANTLY ASSOCIATED WITH HF PATIENTS WHO WERE ON ASPIRIN TREATMENT IN THE 12TH MONTH AND WITHOUT ASPIRIN IN THE 18TH MONTH OF THERAPY (P <0.05). THE GG GENOTYPE IN THE RECESSIVE AND CODOMINANT MODEL OF RS2070959 IN THE UGT1A6 GENE SHOWED A SIGNIFICANT ASSOCIATION WITH ASPIRIN TREATMENT IN THE 12TH MONTH [OR (95% CI): 5.10 (1.31¿19.87), P = 0.018 AND (OR (95% CI): 4.50 (1.05¿19.25), P = 0.054)]. THE AG GENOTYPE IN AN OVER-DOMINANT MODEL OF RS2070959 IN THE UGT1A6 GENE SHOWED A SIGNIFICANT ASSOCIATION WITHOUT ASPIRIN TREATMENT IN THE 18TH MONTH [OR (95% CI): 0.33 (0.12¿0.95), P = 0.032)]. IN SUMMARY, THIS STUDY REPORTS THAT GENOTYPING FOR POLYMORPHISMS OF ITGB3, UGT1A6, AND VKORC1 GENES COULD HELP TO PREVENT AND PREDICT COMPLICATION (THROMBOSIS/BLEEDING) DEVELOPMENT IN HF PATIENTS WITH IMPLANTED LVADS, WHICH WILL IMPROVE THE QUALITY OF LIFE, AND REDUCE THE MORBIDITY AND MORTALITY RATE. THEY STUDY CONCLUDED THAT LVAD COMPLICATIONS DEVELOP NOT ONLY DUE TO THE INCORRECT DOSE OF ANTITHROMBOTIC DRUGS AND THE INFLUENCE OF THE DEVICE¿S NON-PHYSIOLOGICAL SHEAR STRESS (NPSS), BUT ALSO DUE TO THE INHERITED INDIVIDUAL GENETIC CHARACTERISTICS OF HF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020675 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death