BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25204409 · Received May 18, 2026

    Report

    Report Number
    2916596-2026-2916794
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    May 1, 2023
    Report Date
    May 18, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CODES: HEALTH EFFECT - CLINICAL CODES: 1930 - UNSPECIFIED INFECTION. 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 01MAY2023 AS THE PATIENTS WERE IMPLANTED BETWEEN 01MAY2018 AND 01MAY2023. AUTHOR INFORMATION: LLOJI A, JAWAID A, JOSHI A, ET AL. OUTCOMES OF HEARTMATE 3 PUMP EXCHANGES IN A LARGE VOLUME CENTER. J HEART LUNG TRANSPLANT. 2025;44(4):S432. DOI:10.1016/J.HEALUN.2025.02.931. UNIVERSITY OF ROCHESTER MEDICAL CENTER, ROCHESTER, NY. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORT OF INFECTION COULD NOT BE DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE REPORT OF SUSPECTED DEVICE THROMBUS WAS UNABLE TO BE CONFIRMED AS NO PRODUCT WAS AVAILABLE FOR EVALUATION. NO DEVICES WERE RETURNED FOR THIS 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 LOCALIZED INFECTION, DRIVELINE INFECTION, PUMP POCKET OR PSEUDO POCKET INFECTION, STROKE, BLEEDING, PUMP THROMBOSIS, AND CARDIAC ARRHYTHMIA 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. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION, ARRHYTHMIA, AND THROMBOEMBOLISM AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION ALSO INCLUDES INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. SECTION 6 ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE HEARTMATE 3 LVAS PATIENT HANDBOOK REV. A, CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION. 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 THROUGH THE RESEARCH ARTICLE TITLED ¿OUTCOMES OF HEARTMATE 3 PUMP EXCHANGES IN A LARGE VOLUME CENTER¿ THAT HEARTMATE 3 (HM3) MAY BE RELATED TO ARRYTHMIA, INFECTION, STROKE, BLEEDING, THROMBOSIS, NEED FOR PUMP EXCHANGE, AND DEATH. THIS SINGLE-CENTER CASE SERIES EVALUATES OUTCOMES OF HM3¿TO¿HM3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PUMP EXCHANGES PERFORMED AT A HIGH-VOLUME CENTER. BETWEEN MAY 2018 AND MAY 2023, 319 HM3 DEVICES WERE IMPLANTED, AND 7 PATIENTS (ABOUT 2%) REQUIRED PUMP EXCHANGE. ALL INITIAL IMPLANTS WERE PERFORMED VIA BILATERAL THORACOTOMY, AND THIS APPROACH WAS USED FOR MOST EXCHANGES. OF THE 7 PATIENTS WHO UNDERWENT PUMP EXCHANGE, 2 PASSED AWAY, 2 EXPERIENCED A STROKE, 1 EXPERIENCED A DISABLING STROKE, 4 PATIENT'S EXPERIENCED INFECTION, 2 EXPERIENCED BLEEDING, 1 PATIENT EXPERIENCED A GASTROINTESTINAL BLEED, 1 PATIENT EXPERIENCED CARDIAC ARRHYTHMIA, AND 6 OF THE PATIENT'S WERE READMITTED. THE PRIMARY INDICATION FOR PUMP EXCHANGE WAS DEVICE-RELATED INFECTION (71.4%), MOST COMMONLY CAUSED BY PSEUDOMONAS AERUGINOSA, WHILE ACUTE PUMP THROMBOSIS ACCOUNTED FOR THE REMAINING CASES (28.6%). TWO PATIENTS DIED DURING FOLLOW-UP: ONE WITHIN 2 DAYS AFTER EXCHANGE FOR ACUTE THROMBOSIS, AND ONE 2.1 YEARS POST-EXCHANGE. NOTABLY, INFECTION RECURRENCE WAS FREQUENT¿80% OF PATIENTS EXCHANGED FOR INFECTION DEVELOPED A NEW DEVICE-RELATED INFECTION WITHIN ONE YEAR, USUALLY DUE TO A DIFFERENT PATHOGEN¿SUGGESTING RECURRENCE WAS NOT DUE TO INADEQUATE SURGICAL ERADICATION. PATIENTS EXPERIENCED SIGNIFICANT MORBIDITY, AVERAGING TWO REHOSPITALIZATIONS IN THE FIRST YEAR AFTER EXCHANGE. OVERALL, HM3 PUMP EXCHANGE IS ASSOCIATED WITH SUBSTANTIAL MORBIDITY AND MORTALITY BUT REMAINS A VIABLE OPTION FOR PATIENTS WHO ARE NOT TRANSPLANT CANDIDATES. PERSISTENT AND RECURRENT INFECTION REMAINS A MAJOR UNRESOLVED CHALLENGE FOLLOWING HM3-TO-HM3 EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76759 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L