BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 11938080 · Received June 4, 2021

    Report

    Report Number
    3001845648-2021-00438
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    April 26, 2021
    Report Date
    September 24, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. DEVICE EVALUATION: THE ZILBS-635-8-8 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: 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-635-8-8 DEVICES ARE SUBJECT TO 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 EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0065-3). THE INSTRUCTIONS FOR USE (IFU0065-3) STATES THE FOLLOWING: DELIVERY SYSTEM: THE DELIVERY SYSTEM ACCEPTS A 0.35 INCH WIRE GUIDE. THE INFORMATION PROVIDED INDICATES THAT A 0.25 INCH WIRE GUIDE WAS USED. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION AS AN INCORRECT WIRE GUIDE SIZE WAS USED. THE INFORMATION AVAILABLE INDICATES THAT THE PATIENTS ANATOMY WAS TORTUOUS AND THE DELIVERY SYSTEM WAS TRACKED AROUND A TIGHT ANGLE. THE SMALLER THAN RECOMMENDED WIRE-GUIDE MAY NOT HAVE BEEN STRONG ENOUGH IN THIS INSTANCE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 · 0

    SUPPLEMENTAL REPORT BASED ON NEW INFORMATION RECEIVED - USER ERROR INCORRECT SIZE WIRE GUIDE USED 0.025IN.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DOCTOR WANTED TO INSERT THE METAL STENT INTO THE LEFT HEPATIC DUCT. BECAUSE STRICTURE WAS HARD AND DUCT WAS TORTUOUS. HE CHOOSE THE ZILBS-635-8-8. USING DILATION BALLOON, DESPITE THE EXPANSION, THE ZILVER 635-8-8 DID NOT PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834911 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1