BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 10014359 · Received April 30, 2020

    Report

    Report Number
    2134265-2020-05806
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    December 1, 2017
    Report Date
    April 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: JANUARY 2010 THROUGH DECEMBER 2017. LITERATURE CITATION: EUROPEAN SOCIETY OF CARDIOLOGY, EUROPEAN HEART JOURNAL CARDIOVASCULAR IMAGING 2019: 40, 3156-3165 DOI:10.1092/EURHEARTJ/EHZ429.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT TRANSCATHETER VALVE EMBOLIZATION AND MIGRATION (TVEM) OCCURRED. THE RATE OF TVEM WAS ONE OF THE LOWEST FOR THE LOTUS VALVE, WHICH IS RESHEATHABLE EVEN AFTER COMPLETE DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478986 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other