BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10424817 · Received August 19, 2020

    Report

    Report Number
    3001845648-2020-00508
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    October 23, 2014
    Report Date
    December 17, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163018. DEVICE EVALUATION: THE ZILVER 635 BILIARY SELF EXPANDING METAL STENTS OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBERS OF THESE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY SELF EXPANDING METAL STENT DEVICES ARE SUBJECT TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0065-3). THE JAPANESE PACKAGING INSERT C-ES1207M06 SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THE JAPANESE PACKAGING INSERT STATES THE FOLLOWING: WARNINGS: 5) THE SAFETY AND EFFICACY OF COMBINED SIDE-BY-SIDE WITH OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED. EQUIPMENT REQUIRED: 0.89 MM (0.035 INCH) WIRE GUIDE. THE ARTICLE INDICATES THAT SIDE BY SIDE STENT PLACEMENT WAS USED AND, IN SOME INSTANCE, A 0.025¿ WIRE GUIDE WAS USED. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED. THE ARTICLE STATES THAT THE STENTS WERE PLACED SIDE-BY SIDE. THE JAPANESE PACKAGING INSERT PROVIDED WITH THE DEVICE INDICATES THAT THE SAFETY AND EFFICACY OF COMBINED SIDE-BY-SIDE STENT PLACEMENT HAS NOT BEEN ESTABLISHED. IN ADDITION, THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO USE A 0.035¿ WIRE GUIDE. IN SOME INSTANCES, A 0.025¿ WIRE GUIDE WAS USED. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE STUDY ENDOSCOPIC RE-INTERVENTION WAS SUCCESSFUL FOR ALL PATIENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    KAWAKUBO ET AL. 2015 "SINGLE-STEP SIMULTANEOUS SIDE-BY-SIDE PLACEMENT OF A SELF-EXPANDABLE METALLIC STENT WITH A 6-FR DELIVERY SYSTEM FOR UNRESECTABLE MALIGNANT HILAR BILIARY OBSTRUCTION: A FEASIBILITY STUDY." FROM MAY TO SEPTEMBER 2013, 13 CONSECUTIVE PATIENTS WITH UMHBO UNDERWENT SINGLE-STEP SIMULTANEOUS DOUBLE SEMSS PLACEMENT BY THE SBS METHOD AT HOKKAIDO UNIVERSITY HOSPITAL. UNCOVERED SEMSS WITH THE 6-FR DELIVERY SYSTEM MEASURING 10 MM IN DIAMETER AND 80 MM IN LENGTH (ZILVER 635 BILIARY SELF-EXPANDING STENT; COOK (B)(4)) WERE USED IN ALL PATIENTS. THE INCLUSION CRITERIA WERE UMHBO OF BISMUTH II OR HIGHER LEVEL, CONFIRMED PATHOLOGICALLY BY PRIOR TRANSPAPILLARY BILE DUCT BIOPSIES. STENT DYSFUNCTION WAS DEFINED AS RECURRENCE OF BILIARY OBSTRUCTION AND JAUNDICE AND/OR EVIDENCE OF CHOLESTASIS CONFIRMED BY ULTRASONOGRAPHY (US) OR CT, REQUIRING BILIARY RE-INTERVENTION. STENT DYSFUNCTION WAS OBSERVED IN FIVE PATIENTS - THE CAUSES OF STENT DYSFUNCTIONS WERE TUMOR INGROWTH IN FOUR AND WAS BILIARY SLUDGE IN ONE PATIENT. ENDOSCOPIC RE-INTERVENTION WAS SUCCESSFUL IN ALL FIVE PATIENTS. OF THE FOUR PATIENTS WITH TUMOR INGROWTH, TWO PATIENTS REQUIRED BILATERAL PLASTIC STENT PLACEMENT THROUGH EACH SEMSS, WHILE THE REMAINING TWO PATIENTS WERE SUCCESSFULLY MANAGED WITH ONE PLASTIC STENT PLACEMENT. ONE PATIENT WITH BILIARY SLUDGE WAS SUCCESSFULLY MANAGED BY BALLOON CLEANING. THIS FILE WAS CREATED TO CAPTURE THE STENT DYSFUNCTION THAT OCCURRED IN FIVE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890764 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 72 YR Female Required Intervention