BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 18901620 · Received March 14, 2024

    Report

    Report Number
    3001845648-2024-00095
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    February 16, 2024
    Report Date
    August 11, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506241
    PMA / PMN Number
    K163018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ACCORDING TO DR. (B)(6), DURING THE DEPLOYMENT OF SEMS, AS SOON AS 2 CM OF THE STENT WAS DELIVERED, IT GOT STUCK AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM, THE STENT BROKE. THE BROKEN STENT WAS REMOVED WITH THE HELP OF FORCEPS AND THE CASE WAS COMPLETED USING ANOTHER STENT. AS PER HOSPITAL NORM DELIVERY SYSTEM AND RUPTURED STENT WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967522 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK IRELAND LTD G50624 C2066770 10827002506241

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention