BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25046919 · Received April 30, 2026

    Report

    Report Number
    2916596-2026-2916636
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    September 1, 2024
    Report Date
    April 30, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 01SEP2024, SINCE THE DATE OF DATA COLLECTION OCCURRED BETWEEN APRIL 2018 AND SEPTEMBER 2024. AUTHOR INFORMATION: C. VANDER PLUYM, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 44 (2025) 44(4): S178. DOI:10.1016/J.HEALUN.2025.02.359. BOSTON CHILDREN'S HOSPITAL, BOSTON, MA. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT'S INFECTIONS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING INFECTION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE CURRENT REVISION OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE 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 IN THE RESEARCH ARTICLE ¿APIXABAN ANTICOAGULATION FOR HEARTMATE 3 VENTRICULAR ASSIST DEVICE SUPPORT IN CHILDREN AND YOUNG ADULTS: ACTION ANALYSIS OF REAL WORLD UTILIZATION¿ IDENTIFYING THAT THE USE OF APIXABAN IN HM3 PATIENTS RESULTED IN NON- HEMOCOMPATIBILITY-RELATED (HCAE) ADVERSE EVENTS. HOWEVER, 1 PATIENT HAD PUMP INFECTION AND 2 DRIVELINE INFECTIONS. OVERALL, 93.4% OF PATIENTS WERE EITHER TRANSPLANTED OR ALIVE ON DEVICE SUPPORT, WITH 1 DEATH DUE TO FROM PROGRESSIVE AORTIC REGURGITATION AFTER 1446 DAYS OF VAD SUPPORT. THIS IS A RETROSPECTIVE STUDY WHERE PATIENTS FROM THE ACTION REGISTRY WHO UNDERWENT HM3 VAD IMPLANTATION AND RECEIVED APIXABAN ANTICOAGULATION WERE EVALUATED. HCAE AND CLINICAL OUTCOMES WERE ASSESSED. AMONG 325 HM3 PATIENTS, 16 CHILDREN AND YOUNG ADULTS RECEIVED APIXABAN ANTICOAGULATION ACROSS FOUR ACTION CENTERS BETWEEN APRIL 2018 AND SEPTEMBER 2024. APIXABAN WAS INITIATED AT A MEDIAN OF 21 DAYS POST-IMPLANTATION. NINE PATIENTS RECEIVED APIXABAN AS THE PRIMARY ANTICOAGULANT, WHILE THE REST TRANSITIONED FROM VKA. IN THIS SMALL COHORT OF HM3 PATIENTS FROM THE ACTION REGISTRY, APIXABAN WAS EFFECTIVE IN PREVENTING THROMBOSIS AND WAS NOT ASSOCIATED WITH ANY HC RELATED AE. FURTHER STUDIES ARE NEEDED TO EXPLORE THE ROLE OF APIXABAN AS A PRIMARY ANTICOAGULANT IN CHILDREN AND YOUNG ADULTS WITH HM3 VAD SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367802 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R