BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 15333565 · Received September 1, 2022

    Report

    Report Number
    3001845648-2022-00598
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    April 18, 2019
    Report Date
    August 3, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K182980. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    PERFORATION OF BILE DUCT: BILIARY PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322750 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention