BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING STENT

    MDR report key: 10420821 · Received August 18, 2020

    Report

    Report Number
    3005580113-2020-00399
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    August 6, 2009
    Report Date
    August 18, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL.

    Description of Event or Problem · 1

    CHAHAL & BARON 2010 (ZILBS) ¿EXPANDABLE METAL STENTS FOR ENDOSCOPIC BILATERAL STENT-WITHIN-STENT PLACEMENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION.¿ PROCEDURE: UNCOVERED LARGE CELL WIDTH SEMSS (FLEXXUS, CONMED, BILLERICA, MASS) WERE USED IN 10 PATIENTS, THE ZILVER STENT (COOK MEDICAL, (B)(4)) IN 1 PATIENT, AND A SMALL CELL WIDTH SEMS (WALLSTENT, BOSTON SCIENTIFIC, (B)(4)) WAS USED IN 1 PATIENT. THE FIRST SEMS WAS DEPLOYED ACROSS THE BIFURCATION INTO THE LEFT HEPATIC DUCT IN 20 PATIENTS AND THE RIGHT ANTERIOR HEPATIC DUCT IN 1 PATIENT WITH A PREVIOUS LEFT HEPATECTOMY. THE GUIDEWIRE REMAINED IN PLACE, AND THE DELIVERY SYSTEM WAS REMOVED. OVER THE WIRE A STANDARD ACCESSORY (CATHETER OR OCCLUSION BALLOON) WAS PASSED INTO THE FIRST STENT. THE WIRE WAS WITHDRAWN INTO THE CATHETER AND REDIRECTED TO THE CONTRALATERAL INTRAHEPATIC SYSTEM THROUGH THE INTERSTICES OF THE INITIAL SEMS. ALTHOUGH A 5F CATHETER COULD ROUTINELY BE PASSED ACROSS THE INTERSTICES, THE INTERSTICES REQUIRED HYDROSTATIC BALLOON DILATION (4-8 MM) IN 10 CASES. THE SECOND SEMS WAS DEPLOYED THROUGH THE INTERSTICES OF THE INITIAL SEMS, FORMING A Y-SHAPED CONFIGURATION THERE WERE 1 (5%) EARLY AND 7 (33%) LATE COMPLICATIONS RELATED TO STENT OCCLUSIONS THAT REQUIRED ENDOSCOPIC REINTERVENTION. OF THESE 8 PATIENTS WITH STENT OCCLUSIONS, PLASTIC 10F STENTS WERE INSERTED WITHIN THE EXISTING SEMSS IN 4 PATIENTS, ANOTHER UNCOVERED SEMS WAS INSERTED WITHIN THE EXISTING SEMS IN 3, AND MERE STRIPPING OF EXISTING SEMS WAS PERFORMED IN 1 PATIENT (TABLE 1). THE CAUSE OF STENT OCCLUSION WAS TUMOR INGROWTH IN 6 PATIENTS WITH CHOLANGIOCARCINOMA; TISSUE HYPERPLASIA DIAGNOSED WITH CYTOLOGY, HISTOLOGY, AND CHOLANGIOSCOPY IN 1 (HEPATIC LYMPHOMA PATIENT); AND SIGNIFICANT SLUDGE IN 1. THE MEDIAN STENT PATENCY PERIOD WAS 189 DAYS (IQR 90-225 DAYS). AS PER TABLE 1: 3 ZILVER BILIARY 6 X 80 DEVICES WERE PLACED IN TWO PATIENTS: PATIENT 1: MALE, (B)(6) YEAR OLD, 2 ZILVER BILIARY DEVICES PLACED. STENT OCCLUSION OCCURRED, INTERVENTION OCCURRED AFTER 7 MONTHS SEMS LEFT (ANOTHER UNCOVERED SEMS WAS INSERTED WITHIN THE EXISTING SEMS) PATIENT 2: MALE, (B)(6) YEARS OLD, 1 ZILVER BILIARY DEVICE PLACED. STENT OCCLUSION OCCURRED, INTERVENTION OCCURRED AFTER 8 MONTHS PLASTIC 10F B/L (PLASTIC 10F STENTS WERE INSERTED WITHIN THE EXISTING SEMSS) THIS FILE IS CAPTURING THE OCCLUSION AND INTERVENTION OF THE ABOVE TWO PATIENTS WITH ZILVER BILIARY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884127 ZILVER BILIARY SELF-EXPANDING STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention