BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11553378 · Received March 23, 2021

    Report

    Report Number
    3005580113-2021-00048
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 23, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231280
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER THE STENT "SHEERED OFF DURING DEPLOYMENT." SMALL PIECES OF METAL REMAIN INSIDE PATIENT'S BODY, UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446240 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE COOK IRELAND LTD G23128 C1628216 10827002231280

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention