BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9930573 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00207
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    November 4, 2014
    Report Date
    July 2, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K182980. DEVICE EVALUATION: THE ZIB DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. LAB EVALUATION: N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIB 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 . A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIB DEVICE COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE(IFU0040-6). IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE STENT PLACEMENT PROCEDURE OR THE STENT ITSELF. IT IS POSSIBLE THAT THE STENT PLACEMENT PROCEDURE OR THE STENT CAUSED OR CONTRIBUTED TO THE EVENT OF BILIARY TRACT HAEMORRHAGE. BASED ON THE INFORMATION AVAILABLE IT IS LIKELY THAT THE HAEMORRHAGE RESULTED FROM THE STENT PLACEMENT PROCEDURE AS THEY OCCURRED DURING STENT INSERTION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, EXTERNAL DRAINAGE CATHETERS WERE PLACED IN 07 PATIENTS AS A RESULT OF THE HEMORRHAGES IDENTIFIED DURING STENT PLACEMENT. 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

    PMA/510(K)#: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    HUANG ¿ ¿COMPARISON OF UNCOVERED STENT PLACEMENT ACROSS VERSUS ABOVE THE MAIN DUODENAL PAPILLA FOR MALIGNANT BILIARY OBSTRUCTION¿. THE OVERALL LENGTH OF THE OBSTRUCTION AND THE DISTANCE FROM THE END OF OBSTRUCTION TO THE PAPILLA WERE CONFIRMED. THE GUIDE WIRE WAS EXCHANGED FOR A 0.035-INCH GUIDE WIRE (AMPLATZ SUPER STIFF; BOSTON SCIENTIFIC, NATICK, MASSACHUSETTS), AND A SELF-EXPANDING METAL STENT WAS INSERTED THROUGH THE WIRE. STENTS WERE PLACED ACROSS THE PAPILLA IN PATIENTS WITH TUMOR OBSTRUC-TION THE LOWER 2 CM OF THE CBD, AND ABOVE THE PAPILLA IN PATIENTS WITHOUT PERIPAPILLARY OBSTRUCTION. THE STENT PROTRUDED 1 CM INTO THE DUODENUM IF IT WAS INSERTED ACROSS THE PAPILLA. POSTDILATION OF THE STENT WAS NOT NECESSARY. AN 8.5-F EXTERNAL BILIARY DRAINAGE CATHETER (COOK) WAS LEFT ABOVE THE STENT IF NECESSARY. THE DRAINAGE CATHETERS WERE IRRIGATED AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392286 ZILVER BILIARY SELF-EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention