BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24982135 · Received April 24, 2026

    Report

    Report Number
    2916596-2026-02049
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 2, 2024
    Report Date
    April 24, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION, APR2024, SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: F. PAGANI. (2024). IMPACT OF CONCOMITANT SURGICAL PROCEDURES IN A RANDOMIZED CONTROLLED TRIAL OF ASPIRIN REMOVAL IN LEFT VENTRICULAR ASSIST DEVICE PATIENTS - AN ANALYSIS FROM THE ARIES TRIAL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.125. UNIVERSITY OF MICHIGAN, ANN ARBOR, MICHIGAN, USA. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS STROKE, BLEEDING, PUMP THROMBOSIS, VENOUS THROMBOEMBOLISM, AND ARTERIAL NON-CENTRAL NERVOUS SYSTEM (CNS) THROMBOEMBOLISM AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 5, "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿), INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. FURTHERMORE, SECTION 5, UNDER ¿IMPLANT PROCEDURES¿, WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESEARCH ARTICLE TITLED CONCOMITANT SURGICAL PROCEDURES AND ASPIRIN AVOIDANCE WITH LEFT VENTRICULAR ASSIST DEVICE THERAPY SOUGHT TO IDENTIFY IF WITHDRAWAL FROM AN ANTI-THROMBOTIC REGIMEN INCLUDING VITAMIN K ANTAGONIST (VKA) WOULD REMAIN SAFE AND BE ASSOCIATED WITH FEWER BLEEDING COMPLICATIONS IN THE SETTING OF CONCOMITANT SURGICAL PROCEDURES AT THE TIME OF DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION, CONSISTENT WITH THE FINDINGS OF THE OVERALL ARIES-HM3 TRIAL. SURGICAL PROCEDURES WERE CATEGORIZED INTO SUBGROUPS ACCORDING TO VALVULAR OR CORONARY ARTERY BYPASS GRAFTING (CABG), NONVALVULAR OR REVASCULARIZATION PROCEDURES, INCLUDING CLOSURE OF A PATENT FORAMEN OVALE OR LEFT ATRIAL APPENDAGE, OR REMOVAL OF PREIMPLANT EXTRACORPOREAL MEMBRANE OXYGENATION CANNULAS, RIGHT HEART FAILURE SUPPORT DEVICE REMOVAL, LEFT HEART SUPPORT DEVICE REMOVAL, AND OTHER NON-CLASSIFIED PROCEDURES. OF 628 RANDOMIZED PATIENTS, A TOTAL OF 589 PATIENTS CONTRIBUTED TO THE PRIMARY OUTCOME ANALYSIS. THE PATIENTS WERE ENROLLED ACROSS 51 SITES IN NORTH AMERICA (UNITED STATES, CANADA), EUROPE (CZECH REPUBLIC, AUSTRIA, ITALY, FRANCE, UNITED KINGDOM), KAZAKHSTAN, AND AUSTRALIA AND RANDOMLY ASSIGNED TO RECEIVE EITHER PLACEBO OR ANTIPLATELET THERAPY WITH ASPIRIN (ASA) (100 MG DAILY) TREATMENTS IN EQUAL PROPORTIONS FOLLOWING THE SECOND TO SEVENTH POST IMPLANTATION DAY. PRIMARY AND SECONDARY OUTCOME ENDPOINT MEASURE WERE THE RATE OF SURVIVAL WITHOUT EXPERIENCING MAJOR HEMOCOMPATIBILITY-RELATED ADVERSE EVENTS (HRAES), NOT RELATED TO THE LVAD IMPLANT SURGERY, INCLUDING STROKE, PUMP THROMBOSIS, ARTERIAL PERIPHERAL THROMBOEMBOLISM AND MAJOR SIGNIFICANT NON-SURGICAL BLEEDING DEFINED TO INCLUDE MODERATE, SEVERE AND GASTROINTESTINAL BLEEDING INCIDENTS. THE ANALYSIS INDICATED THAT THERE WAS NO EVIDENCE TO SUPPORT THAT ASA HAD A SIGNIFICANT IMPACT ON HEMOCOMPATIBILITY RELATED COMPLICATIONS REGARDLESS OF CONCOMITANT SURGICAL PROCEDURE. SECONDARY ENDPOINT OF NONSURGICAL MAJOR HEMORRHAGIC EVENTS INDICATED A DECREASE IN THE NUMBER STROKE, MAJOR THROMBOTIC EVENTS, AND BLEEDING REGARDLESS OF WHETHER OR NOT THE SUBJECT RECEIVED A CONCOMITANT SURGICAL PROCEDURE. THE OBSERVED REDUCTION IN REHOSPITALIZATION DAYS DUE TO BLEEDING DID NOT DIFFER ACROSS THE TREATMENT ARMS BY CONCOMITANT SURGICAL PROCEDURE, NO SIGNIFICANT DIFFERENCES BETWEEN THE PLACEBO AND ASA GROUPS, INDEPENDENT OF WHETHER A CONCOMITANT SURGICAL PROCEDURE WAS PERFORMED. THE STUDY IDENTIFIED THAT A TOTAL OF 24 PATIENTS RECEIVED EXPLANTS/HEART TRANSPLANTS WITHIN 12 MONTHS OF LVAS IMPLANT. A TOTAL OF 175 PATIENTS EXPERIENCED A TOTAL OF 239 MAJOR HEMORRHAGIC EVENTS. A TOTAL OF 15 PATIENTS EXPERIENCED A TOTAL OF 16 MAJOR THROMBOTIC EVENTS. A TOTAL OF 19 PATIENTS EXPERIENCED A TOTAL OF 20 STROKE EVENTS. A TOTAL OF 171 PATIENTS EXPERIENCED A TOTAL OF 234 BLEEDING EVENTS. IT WAS CONCLUDED THAT CONCOMITANT SURGICAL PROCEDURES IN PATIENTS RECEIVING HEARTMATE 3 LVAD IMPLANTATION DO NOT INCREASE NONSURGICAL BLEEDING IF ASA IS REMOVED FROM THE ANTITHROMBOTIC REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039826 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L