BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 11609678 · Received April 2, 2021

    Report

    Report Number
    3005580113-2021-00054
    Event Type
    Injury
    Date Received
    April 2, 2021
    Report Date
    April 2, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIO STENT, ILIAC. PRODUCT CODE: QAN.

    Description of Event or Problem · 1

    AS REPORTED BY THE INITIAL REPORTER "STENT PLACEMENT IN RT ILIAC VEIN. SYMPTOMS RESOLVED AT 30DAY F/U. NO ADVERSE EVENTS FOLLOWING. (B)(6) 2020 RT KNEE REPLACEMENT. (B)(6) 2020 CHEST PX AND SOB. QUESTIONED ENDOCARDITIS DX. MARCH 2021 SAW MIGRATED STENT IN RT VENTRICLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508939 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention