BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 12031807 · Received June 21, 2021

    Report

    Report Number
    3005580113-2021-00073
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 21, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, 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 INITIALLY REPORTED TO CUSTOMER RELATIONS: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A BILATERAL VENOUS STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57445, WAS USED. THE RIGHT SIDE DEPLOYED AS INTENDED. THE LEFT SIDE AFTER DEPLOYMENT THE STENT DID NOT FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO BALLOON THE STENT BUT IT STILL LOOKED DEFORMED. THE PHYSICIAN THEN REALIGNED WITH A WALL STENT AND ALIGNMENT LOOKED BETTER. PHYSICIAN NOTED THE LEFT SIDE HAD A HARD LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933164 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57445 C1766386 10827002574455

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention