BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 20853952 · Received December 5, 2024

    Report

    Report Number
    3001845648-2024-00760
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    September 27, 2023
    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/510(K)#: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS 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 ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    MITSURU OKUNO, 2023 ¿ THE EVALUATION OF BILATERAL STENTING USING BRAIDED OR LASER-CUT SELF-EXPANDABLE METALLIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION. THE BILE DUCT FOR SEMS PLACEMENT WAS IDENTIFIED USING MULTIDETECTOR COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY. TRANSPAPILLARY BILATERAL SEMS PLACEMENT BY THE SIS METHOD WAS PERFORMED USING A STANDARD DUODENOSCOPE (TJF-200, JF-240, JF-260V, OR TJF-260V; OLYMPUS MEDICAL SYSTEM, TOKYO, JAPAN) FOR NORMAL ANATOMY CASES AND A SHORT DOUBLE-BALLOON ENDOSCOPE (EI-580BT; FUJIFILM, TOKYO, JAPAN) FOR ROUX-EN-Y ANATOMY CASES. AFTER CHOLANGIOGRAPHY, A GUIDEWIRE (0.025- INCH VISIGLIDE2: OLYMPUS MEDICAL SYSTEM, TOKYO, JAPAN; 0.025-INCH M-THROUGH TM: ASAHI INTECC, AICHI, JAPAN; OR 0.025-INCH ENDOSELECTOR: BOSTONSCIENTIFIC JAPAN, TOKYO, JAPAN) WAS INSERTED INTO THE INTRAHEPATIC BILE DUCT (IHBD). THE PATIENTS UNDERWENT ENDOSCOPIC SPHINCTEROTOMY (ES) OR ENDOSCOPIC PAPILLARY BALLOON DILATION AFTER PLACING A GUIDEWIRE IF NECESSARY; THEN, THE FOLLOWING GUIDEWIRE WAS PLACED ON THE OPPOSITE IHBD SIDE. THE FIRST UNCOVERED SEMS WAS DEPLOYED ACROSS THE CONFLUENCE ON ONE SIDE OF THE IHBD. THE GUIDEWIRE WAS ACCESSED FROM THE OPPOSITE SIDE OF THE IHBD VIA THE MESH OF THE FIRST SEMS, AND THE SECOND UNCOVERED SEMS WAS DEPLOYED THROUGH THE FIRST SEMS. EXPERIENCED ENDOSCOPISTS, WHO WERE FACULTY MEMBERS AT THE THREE MEDICAL CENTERS, PERFORMED ALL ENDOSCOPIC PROCEDURES. USE ERROR: STENT IN STENT (SIS). THE FIRST UNCOVERED SEMS WAS DEPLOYED ACROSS THE CONFLUENCE ON ONE SIDE OF THE IHBD. THE GUIDEWIRE WAS ACCESSED FROM THE OPPOSITE SIDE OF THE IHBD VIA THE MESH OF THE FIRST SEMS, AND THE SECOND UNCOVERED SEMS WAS DEPLOYED THROUGH THE FIRST SEMS. USER ERROR: 0.025-INCH VISIGLIDE2, 0.025-INCH M-THROUGH TM OR 0.025-INCH ENDOSELECTOR) WAS USED. NO HEALTH CONSEQUENCES OR IMPACT. AVERAGE AGE 76. WOMEN 14 (42.4%).

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS 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 ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468656 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 Female