BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23697761 · Received December 2, 2025

    Report

    Report Number
    2916596-2025-07717
    Event Type
    Death
    Date Received
    December 2, 2025
    Date of Event
    November 1, 2020
    Report Date
    January 20, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. KANWAR, M., PALAK, S., ET AL., THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY: HEART FAILURE (2025). IMPACT OF PREOPERATIVE TEMPORARY MECHANICAL CIRCULATORY SUPPORT ON DURABLE LVAD OUTCOMES: AN ANALYSIS OF THE SOCIETY OF THORACIC SURGEONS NATIONAL INTERMACS DATABASE, VOL.13(11), 1-13. HTTPS://DOI.ORG/10.1016/J.JCHF.2025.102671 DIVISION OF CARDIOLOGY, UNIVERSITY OF CHICAGO PRITZKER SCHOOL OF MEDICINE, CHICAGO, ILLINOIS, USA; INOVA SCHAR HEART AND VASCULAR, FALLS CHURCH, VIRGINIA, DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, UNIVERSITY OF MICHIGAN, ANN ARBOR, MICHIGAN, DEPARTMENT OF CARDIOTHORACIC SURGERY, ALBERT EINSTEIN COLLEGE OF MEDICINE, MONTEFIORE MEDICAL CENTER, NEW YORK, NEW YORK, BAYLOR SCOTT AND WHITE HEALTH, ADVANCED HEART FAILURE PROGRAM CLINIC, TEMPLE, TEXAS, INSTITUTE FOR ADVANCED CARDIAC CARE, MEDICAL CITY HEALTHCARE, DALLAS, TEXAS, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NEW YORK, PIEDMONT HEART INSTITUTE, DEPARTMENT OF CARDIAC SURGERY, ATLANTA, GEORGIA, KIRKLIN SOLUTIONS, INC, BIRMINGHAM, ALABAMA, AND THE DEPARTMENT OF CARDIAC SURGERY, UNIVERSITY OF MICHIGAN, ANN ARBOR, MICHIGAN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING DEATH, INFECTION, BLEEDING, MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION, AND RESPIRATORY FAILURE. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. 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 COHORT RESEARCH ARTICLE TITLED ¿IMPACT OF PREOPERATIVE TEMPORARY MECHANICAL CIRCULATORY SUPPORT ON DURABLE LVAD OUTCOMES¿ THAT HEARTMATE 3 IS ASSOCIATED WITH STROKE, RENAL DYSFUNCTION, HEPATIC DYSFUNCTION, AND DEATH DUE TO CIRCULATORY ISSUES, DEVICE MALFUNCTION, BLEEDING, INFECTION, MULTI-SYSTEM ORGAN FAILURE, NEUROLOGICAL DYSFUNCTION, RESPIRATORY ISSUES, HEART FAILURE, AND SUDDEN DEATH. IN THIS ANALYSIS, THERE WERE OUTCOMES OF PATIENTS UNDERGOING DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION STRATIFIED BY PREOPERATIVE TEMPORARY MECHANICAL CIRCULATORY SUPPORT (TMCS) SUPPORT. THE DEFINED CHARACTERISTICS AND OUTCOMES IN PATIENTS UNDERGOING HEARTMATE 3 (HM3) LVAD IMPLANTATION WHILE ON TMCS SUPPORT FROM THE SOCIETY OF THORACIC SURGEONS INTERMACS (STSI; INTERAGENCY REGISTRY FOR MECHANICALLY ASSISTED CIRCULATORY SUPPORT) DATABASE, STATED THAT MORTALITY RATES AND ADVERSE EVENTS COULD VARY BASED ON TMCS TYPE. ADULT PATIENTS WHO UNDERWENT IMPLANTATION OF A FULLY MAGNETICALLY LEVITATED (FML) LVAD FROM 2020 TO 2024 AS INTERMACS PROFILES 1-3 WERE INCLUDED. PRIMARY OUTCOMES ANALYZED WERE 1- AND 2-YEAR MORTALITY AND RATES OF STROKE. OUTCOMES WERE COMPARED IN COHORTS WITH NO TMCS, INTRA-AORTIC BALLOON PUMP (IABP), HIGH-FLOW MICRO-AXIAL FLOW PUMP (HF-MP), AND VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION. A MULTIVARIABLE PROPORTIONAL HAZARDS MODEL WAS USED TO DETERMINE PREOPERATIVE AND PERIOPERATIVE CHARACTERISTICS ASSOCIATED WITH PATIENT SURVIVAL. A PROPENSITY SCORE MATCHING (PSM) ANALYSIS WAS PERFORMED TO COMPARE HF-MP WITH NO TMCS. A TOTAL OF 5,787 LVAD PATIENTS MET INCLUSION CRITERIA; 3,863 (66.7%) WERE SUPPORTED ON TMCS AT THE TIME OF LVAD IMPLANTATION. THE USE OF THE HF-MP INCREASED SIGNIFICANTLY OVER THE STUDY PERIOD (19.1% TO 35.1%, P < 0.001) WHEREAS THE USE OF IABP DECREASED (41.2% TO 27.3%, P < 0.001). OVERALL PATIENT SURVIVAL WAS 82.9% AND 77.9% AT 1 AND 2 YEARS, RESPECTIVELY. PATIENTS ON EXTRACORPOREAL MEMBRANE OXYGENATION HAD THE LOWEST 1- AND 2-YEAR SURVIVAL (70.6% AND 67.1%) WHEREAS PATIENTS ON IABP (85.7% AND 81.2%) AND HF-MP (82.9% AND 77.5%) HAD SURVIVAL RATES COMPARABLE TO PATIENTS WITHOUT TMCS THERAPY (82.4% AND 77%, RESPECTIVELY). IN THE ADJUSTED MULTIVARIABLE MODEL, BOTH HF-MP (HR: 0.71 [95% CI: 0.59-0.84]; P = 0.001) AND IABP (HR: 0.74 [95% CI: 0.63-0.86]; P = 0.001) WERE ASSOCIATED WITH IMPROVED SURVIVAL COMPARED TO NO TMCS. IN THE PROPENSITY SCORE MATCHING COHORT, RATES OF SURVIVAL AT 1 AND 2 YEARS WERE 85.2% VS 80.5%, RESPECTIVELY, AND 79.9% VS 74.3% FOR HF-MP, RESPECTIVELY, VS NO TMCS THERAPY (P = 0.009), WHEREAS RATES OF FREEDOM FROM STROKE AT 1 YEAR WERE SIMILAR AT 93.1% AND 93.9% (P = 0.33), RESPECTIVELY. SEVERAL PATIENT CHARACTERISTICS WERE ASSOCIATED WITH REDUCED SURVIVAL AFTER LVAD IMPLANTATION INCLUDING ABNORMAL BLOOD UREA NITROGEN, HIGHER TOTAL BILIRUBIN, INCREASING AGE, AND PRIOR CABG. PATIENT OUTCOMES INCLUDED MORTALITY AT 1- AND 2-YEARS POST LVAD IMPLANTATION AS WELL AS FREEDOM FROM STROKE. STROKE WAS DEFINED PER STS INTERMACS ADVERSE EVENT CRITERIA AND INCLUDED ISCHEMIC STROKE WITH OR WITHOUT HEMORRHAGIC CONVERSION, SYMPTOMATIC INTRACEREBRAL HEMORRHAGE, OR AN EPISODE OF ACUTE FOCAL NEUROLOGICAL SIGNS OR SYMPTOMS AND/OR HEADACHE PRESUMED TO BE CAUSED BY CENTRAL NERVOUS SYSTEM ISCHEMIA OR HEMORRHAGE PERSISTING 24 HOURS OR UNTIL DEATH BUT WITHOUT INSUFFICIENT NEUROIMAGING PERFORMED TO BE CLASSIFIED AS ONE OF THE ABOVE. SECONDARY OUTCOMES OF INTEREST WERE LENGTH OF STAY (LOS) AND THE NEED FOR BIVENTRICULAR SUPPORT AT THE TIME OF LVAD IMPLANTATION. SURVIVAL ANALYSES WERE PERFORMED TO COMPARE DEVICE SURVIVAL BETWEEN STUDY GROUPS. TIME ZERO WAS DEFINED AS THE DATE OF THE DURABLE FML IMPLANTATION. FOR DEVICE SURVIVAL ANALYSIS, THE EVENT WAS DEATH WHILE ON THE DEVICE; PATIENTS WERE CENSORED AT TRANSPLANTATION, CESSATION OF SUPPORT FOR RECOVERY, OR AT 2 YEARS, WHICHEVER OCCURRED FIRST. SIMILARLY, FOR FREEDOM-FROM-STROKE ANALYSES, THE EVENT WAS STROKE, WITH CENSORING AT DEATH, TRANSPLANTATION, CESSATION OF SUPPORT, STUDY EXIT, OR AT 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783480 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death