BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 21148381 · Received January 14, 2025

    Report

    Report Number
    2916596-2025-00230
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    January 1, 2023
    Report Date
    January 14, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013266
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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. DATE OF EVENT HAS BEEN ENTERED AS 01JAN2023 SINCE THE PATIENTS WERE IMPLANTED BETWEEN 2013 TO 2023. SILVIA AJELLO ET AL., ASAIO JOURNAL70.11: E150-E152. DOI: 10.1097/MAT.0000000000002201. CARDIAC INTENSIVE CARE UNIT, ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO (IRCCS) SAN RAFFAELE SCIENTIFIC INSTITUTE, MILAN, ITALY. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION B, IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS BLEEDING AS AN ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. 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 ¿IMPELLA AS BRIDGE TO DURABLE LEFT VENTRICULAR ASSIST DEVICE IN ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK PATIENTS?¿ IDENTIFYING THAT HEARTMATE 3 (HM3) MAY BE RELATED TO BLEEDING POST-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT THAT REQUIRED SURGICAL REVISION. FROM 2013 TO 2023, 21 PATIENTS WITH CARDIOGENIC SHOCK AFTER ACUTE MYOCARDIAL INFARCTION WERE SUPPORTED WITH AN IMPELLA DEVICE AS A BRIDGE TO DURABLE LVAD IMPLANTATION. ALL PATIENTS (100%) WERE SUCCESSFULLY BRIDGED TO DURABLE LVAD IMPLANTATION. SEVEN PATIENTS (33%) WERE IMPLANTED WITH THE HEARTWARE LVAD (HVAD; MEDTRONIC INC.), AND 14 (67%) WITH THE HEARTMATE 3. AFTER LVAD IMPLANT, 5 PATIENTS (24%) REQUIRED SURGICAL REVISION FOR BLEEDING WITHIN 48 HOURS, AND 8 PATIENTS (38%) REQUIRED SURGICAL REVISION FOR BLEEDING WITHIN 7 DAYS POST-LVAD IMPLANT. THIS DATA FIRST SHOWED THAT BRIDGING ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI-CS) PATIENTS TO DURABLE LVAD IMPLANTATION WITH AN IMPELLA DEVICE WAS FEASIBLE WITHIN FEW WEEKS FROM THE INDEX EVENT IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256528 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106523 00813024013266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown