BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER

    MDR report key: 17536753 · Received August 12, 2023

    Report

    Report Number
    MW5143637
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    June 6, 2019
    Report Date
    June 20, 2019
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FGE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING AN ERCP PERFORMED BY DR. (B)(6) OF (B)(6) HOSPITAL ON (B)(6) 2019, TWO COOK ZILVER STENTS FAILED TO DEPLOY. THE ANATOMY WAS TORTUOUS AND HEAVILY STRICTURED AND THE PROCEDURE COULD NOT BE COMPLETED. THE PATIENT WAS REPORTED TO BE OKAY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216899 ZILVER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown