BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 19556294 · Received June 18, 2024

    Report

    Report Number
    3001845648-2024-00275
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 7, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    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

    DESCRIPTION OF EVENT: AFTER THE STENT WAS PLACED IN THE LESION LOCATION, IT WAS FOUND THAT IT COULD NOT BE RELEASED, AND SEVERAL ATTEMPTS FAILED TO RELEASE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THE NEW STENT WITHOUT ADVERSE EFFECTS ON THE PATIENT. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332550 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C2102634 10827002372709

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male