BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 20863754 · Received December 6, 2024

    Report

    Report Number
    3001845648-2024-00769
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    January 31, 2024
    Report Date
    July 29, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K182980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    TAKUYA SHIMOSAKA, 2024 ¿ PARTIAL STENT-IN-STENT METHOD WITH AN UNCOVERED SELF-EXPANDABLE METALLIC STENT FOR UNRESECTABLE MALIGNANT HILAR BILE DUCT OBSTRUCTION. TJF-Q290V OR JF-260V (OLYMPUS OPTICAL CO., LTD., TOKYO, JAPAN) WAS USED FOR THE PROCEDURE. SEMSS WERE SELECTED AT THE OPERATOR¿S DISCRETION FROM FIVE TYPES: ZILVER 635 STENT (COOK MEDICAL JAPAN G.K., TOKYO, JAPAN), BILERUSH STENT (PIOLAX, INC., KANAGAWA, JAPAN), ZEO STENT V (ZEON MEDICAL INC., TOKYO, JAPAN), NITI-S BILIARY STENT (CENTURY MEDICAL, INC., TOKYO, JAPAN), AND YABUSAME (KANEKA MEDIX CORP., OSAKA, JAPAN). AFTER BILE DUCT INTUBATION, A GUIDEWIRE WAS PLACED IN EACH BILE DUCT TARGETED FOR STENTING, AND THE FIRST SEMS WAS PLACED ALONG ONE GUIDEWIRE. SUBSEQUENTLY, A GUIDEWIRE WAS INSERTED INTO THE CONTRALATERAL BILE DUCT THROUGH THE MESH GAP FROM INSIDE THE ALREADY PLACED SEMS USING THE OTHER GUIDEWIRE AS A LANDMARK, AND A SECOND SEMS WAS PLACED USING THIS GUIDEWIRE. THE PROCEDURE DESCRIBED ABOVE WAS REPEATED FOR THE PLACEMENT OF THE THIRD AND SUBSEQUENT SEMS. THIS COMPLAINT WILL CAPTURE THE USE ERROR OF PARTIAL STENT IN STENT PATIENT OUTCOME NOT PROVIDED IN THE LITERATURE ARTICLE. 59 PATIENTS, SEX: MALE - 39 FEMALE - 20, AGE (YEARS), MEDIAN (IQR) - 76 (68-81).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120468 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male