BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23945186 · Received January 2, 2026

    Report

    Report Number
    2916596-2025-08016
    Event Type
    Death
    Date Received
    January 2, 2026
    Date of Event
    December 31, 2023
    Report Date
    January 2, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067039323
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: 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. DATE OF EVENT HAS BEEN ESTIMATED AS 31DEC2023 AS PATIENT ANALYSIS OF ALL PRIMARY CONTINUOUS-FLOW LVAD IMPLANTATIONS RECORDED IN EUROMACS BETWEEN JANUARY 1, 2011, AND DECEMBER 31, 2023. AUTHOR INFORMATION: GUGLIELMO G., BALDETTI, K., VEEN, K., ET AL. (2025). TRADE-OFF BETWEEN BLEEDING AND ISCHEMIC EVENTS FROM LEFT VENTRICULAR ASSIST DEVICES: A EUROMACS REGISTRY ANALYSIS. JOURNAL OF AMERICAN COLLEGE OF CARDIOLOGY, 86(15), 1111-1123. HTTPS://DOI.ORG/10.1016/J.JACC.2025.07.054. EPUB 2025 AUG 27. PMID: 40864013. CARDIOVASCULAR AND THORACIC DEPARTMENT, CITTÀ DELLA SALUTE E DELLA SCIENZA HOSPITAL, TURIN, ITALY; DEPARTMENT OF MEDICAL SCIENCES, UNIVERSITY OF TURIN, TURIN, ITALY; CARDIAC INTENSIVE CARE UNIT, ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO SAN RAFFAELE SCIENTIFIC INSTITUTE, MILAN, ITALY; DEPARTMENT OF CARDIOTHORACIC SURGERY, ERASMUS MEDICAL CENTER, ROTTERDAM, THE NETHERLANDS; DEPARTMENT OF CARDIOVASCULAR SURGERY, HAMBURG, GERMANY; DEPARTMENT OF CARDIOLOGY, CARDIOVASCULAR INSTITUTE, ERASMUS UNIVERSITY MEDICAL CENTER, ROTTERDAM, THE NETHERLANDS; DEPARTMENT OF CARDIOTHORACIC SURGERY, OSLO UNIVERSITY HOSPITAL, OSLO, NORWAY; KAROLINSKA UNIVERSITY HOSPITAL, STOCKHOLM, SWEDEN; DEPARTMENT OF MEDICINE, KAROLINSKA INSTITUTET, STOCKHOLM, SWEDEN; INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE, PRAGUE, CZECH REPUBLIC; EGE UNIVERSITY HOSPITAL, IZMIR, TURKEY; UNIVERSITY MEDICAL CENTER, ASTANA, KAZAKHSTAN; DEPARTMENT OF SURGICAL SCIENCES, UNIVERSITY OF TURIN, TURIN, ITALY; PHD PROGRAMME IN BIOENGINEERING AND MEDICAL-SURGICAL SCIENCES, UNIVERSITY OF TURIN, TURIN, ITALY; CARDIOVASCULAR DEPARTMENT, MARIA CECILIA HOSPITAL, GRUPPO VILLA MARIA CARE AND RESEARCH, COTIGNOLA, ITALY; VIENNA MEDICAL UNIVERSITY, VIENNA, AUSTRIA; DEPARTMENT OF THORACIC AND CARDIOVASCULAR SURGERY, UNIVERSITY HOSPITAL WÜRZBURG, WÜRZBURG, GERMANY; HERZ- UND DIABETESZENTRUM NORTH RHINE-WESTPHALIA, BAD OEYNHAUSEN, GERMANY; KATHOLIEKE UNIVERSITEIT LEUVEN, LEUVEN, BELGIUM; EUROMACS (EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT), EACTS HOUSE, WINDSOR, UNITED KINGDOM; DEPARTMENT OF CARDIOTHORACIC AND VASCULAR SURGERY, DEUTSCHES HERZZENTRUM DER CHARITÉ, BERLIN, GERMANY; CHARITÉ¿UNIVERSITÄTSMEDIZIN BERLIN, FREIE UNIVERSITÄT BERLIN AND HUMBOLDT-UNIVERSITÄT ZU BERLIN, BERLIN, GERMANY; AND THE GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH, PARTNER SITE BERLIN, BERLIN, GERMANY. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS 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 IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING DEATH, 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 "TRADE-OFF BETWEEN BLEEDING AND ISCHEMIC EVENTS FROM LEFT VENTRICULAR ASSIST DEVICES: A EUROMACS REGISTRY ANALYSIS" THAT HEARTMATE 3 MAY BE ASSOCIATED WITH HEMOCOMPATIBILITY-RELATED ADVERSE EVENTS, BLEEDING, AND DEATH. THE AUTHORS SOUGHT TO CHARACTERIZE THE OPPOSING RISK OF ISCHEMIC AND BLEEDING HEMOCOMPATIBILITY-RELATED ADVERSE EVENTS (HRAES) IN LEFT VENTRICULAR ACCESS DEVICE (LVAD) CARRIERS WITH CONTEMPORARY PRACTICE. THE RESEARCH INCLUDED 4,320 PATIENTS UNDERGOING CENTRIFUGAL-FLOW LVAD IMPLANTATION (HEARTWARE [HVAD] COHORT: 2,088, HEARTMATE 3(HM3) COHORT: 2,232) IN EUROMACS (EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT). FIRST ISCHEMIC HRAES (ISCHEMIC STROKE, PUMP THROMBOSIS, AND ARTERIAL NONCENTRAL NERVOUS SYSTEM THROMBOEMBOLISM) AND FIRST MAJOR NONSURGICAL BLEEDING HRAES (INTRACRANIAL AND NON-INTRACRANIAL) OCCURRING BETWEEN 2 WEEKS AND 2 YEARS FROM LVAD IMPLANTATION WERE EVALUATED. A LOWER INCIDENCE IN ISCHEMIC (2.9% VS 15.3% PER 100 PATIENT-YEARS; P < 0.001) AND BLEEDING (11.8% VS 18%; P < 0.001) HRAES WAS OBSERVED IN THE HM3 COHORT AS COMPARED TO THE HVAD COHORT, WITH THE DECREASE BEING PARTICULARLY PRONOUNCED FOR ISCHEMIC HRAES. THE RESULTS WERE CONSISTENT FOR ALL SUBTYPES OF EVENTS AND BY SUBPERIODS (15-90, 91-365, >365 DAYS). DESPITE HIGHER ABSOLUTE RISKS IN THE HVAD COHORT, THE TRADE-OFF BETWEEN ISCHEMIC AND BLEEDING HRAES WAS BETTER MATCHED IN THE HVAD AS COMPARED TO THE HM3 COHORTS (BLEEDING EVENTS ¿ ISCHEMIC EVENTS: 2.7% VS 8.9% PER 100 PATIENT-YEARS; P < 0.001), WITH A PERSISTENTLY PREVALENT BLEEDING RISK IN HM3 CARRIERS ACROSS SUBPERIODS. ISCHEMIC AND BLEEDING HRAES WERE ASSOCIATED WITH ALL-CAUSE DEATH IN BOTH COHORTS. ADVANCES IN PUMP TECHNOLOGY HAVE SIGNIFICANTLY REDUCED HRAES IN REAL-WORLD LVAD CARRIERS AND HAVE RESHAPED THE BALANCE BETWEEN ISCHEMIC AND BLEEDING RISKS UNDER CURRENT MANAGEMENT. THE ONGOING EXCEEDING BLEEDING RISK OBSERVED IN CONTEMPORARY PRACTICE UNDERSCORES THE URGENT NEED FOR NOVEL ANTITHROMBOTIC STRATEGIES THAT BETTER ALIGN WITH THE RESIDUAL ISCHEMIC AND BLEEDING PROFILES OF LVAD PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 05415067039323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death