BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11281018 · Received February 4, 2021

    Report

    Report Number
    2134265-2021-01120
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    PMA / PMN Number
    P180029
    Removal / Correction Number
    92630745-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY IN (B)(6) 2020 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN AND OTHER ANTIPLATELET MEDICATIONS. AN ISLEEVE INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 25 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED COMPLETE AND PARTIAL RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). FOUR DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN, CLOPIDOGREL AND WARFARIN. IN (B)(6) 2021, 82 DAYS POST INDEX PROCEDURE, A CT SCAN REVEALED PROSTHETIC AORTIC VALVE THROMBOSIS. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. THE EVENT WAS TREATED MEDICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179763 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0025319451

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention