BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 9792905 · Received March 5, 2020

    Report

    Report Number
    3001845648-2020-00145
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    November 3, 2017
    Report Date
    October 15, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ZILBS 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: PRIOR TO DISTRIBUTION, ZILBS DEVICES ARE SUBJECTED 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. AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU(IFU0125-0) . STENT IN STENT PLACEMENT IS NOT DESCRIBED IN THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE USER DEPLOYED WITH STENT IN STENT PLACEMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE ADVERSE EFFECTS WERE CHOLANGITIS AND/OR JAUNDICE, ELEVATED LIVER ENZYME LEVELS, AND BILE DUCT DILATION. 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. HONG ¿ENDOSCOPIC REINTERVENTION FOR STENT MALFUNCTION AFTER STENT-IN-STENT DEPLOYMENT FOR MALIGNANT HILAR OBSTRUCTION¿. TO MANAGE HILAR OBSTRUCTION, ENDOSCOPIC BILATERAL STENTING WAS PERFORMED USING THE SIS DEPLOYMENT METHOD. THE Y-TYPE STENT (HANAROSTENT BILIARY HILAR UNCOVERED; M.I. TECH INC., SEOUL, SOUTH KOREA) AND ZILVER STENT WERE USED AS THE FIRST AND SECOND METAL STENTS, RESPECTIVELY.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: EXACT RPN UNKNOWN. PROVIDED FOR ALL ZILBS DEVICES K163018 OR K020788. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    HONG ¿ENDOSCOPIC REINTERVENTION FOR STENT MALFUNCTION AFTER STENT-IN-STENT DEPLOYMENT FOR MALIGNANT HILAR OBSTRUCTION¿. TO MANAGE HILAR OBSTRUCTION, ENDOSCOPIC BILATERAL STENTING WAS PERFORMED USING THE SIS DEPLOYMENT METHOD. THE Y-TYPE STENT (HANAROSTENT BILIARY HILAR UNCOVERED; M.I. TECH INC., SEOUL, SOUTH KOREA) AND ZILVER STENT WERE USED AS THE FIRST AND SECOND METAL STENTS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257267 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