BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10424606 · Received August 19, 2020

    Report

    Report Number
    3001845648-2020-00510
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    August 6, 2009
    Report Date
    July 30, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K163018. THE ZILBS-635-6-8 DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILBS-635-6-8 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT SHOULD BE NOTED THAT STENT OCCLUSION IS LISTED AS AN ADDITIONAL ADVERSE EVENT THAT CAN OCCUR WITH BILIARY STENT PLACEMENT WITHIN THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE LITERATURE INDICATES THAT THE CAUSES OF STENT OCCLUSION WAS TUMOR INGROWTH WITH CHOLANGIOCARCINOMA; TISSUE HYPERPLASIA DIAGNOSED WITH CYTOLOGY, HISTOLOGY, CHOLANGIOSCOPY AND SIGNIFICANT SLUDGE. IT IS ALSO KNOWN THAT THE PATIENTS IN THE STUDY SUFFERED WITH MALIGNANT BILIARY HILAR OBSTRUCTION AND WERE REFERRED FOR ENDOSCOPIC PALLIATION OF OBSTRUCTION JAUNDICE. THEREFORE, A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/UNDERLYING CONDITIONS. IT SHOULD ALSO BE NOTED THAT STENT OCCLUSION IS LISTED AS AN ADDITIONAL ADVERSE EVENT THAT CAN OCCUR WITH BILIARY STENT PLACEMENT WITHIN THE INSTRUCTIONS FOR USE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, ALL THE PATIENTS REQUIRED AN ADDITIONAL INTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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, BLOOMINGTON, IND) IN 1 PATIENT, AND A SMALL CELL WIDTH SEMS (WALLSTENT, BOSTON SCIENTIFIC, NATICK, MASS) 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, 57 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, 66 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
    889993 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 Required Intervention