BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10426332 · Received August 19, 2020

    Report

    Report Number
    3001845648-2020-00507
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    October 23, 2014
    Report Date
    October 18, 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

    PMA/510(K) # P050017/S002 AND S003. 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. 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 (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 ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE INFECTION/INFLAMMATION DEVELOPED BECAUSE OF THE PATIENTS EXPERIENCING SEGMENTAL CHOLANGITIS (2 PATIENTS), LIVER ABSCESS (2 PATIENTS) AND CHOLECYSTITIS (1PATIENT). PATIENT PRE-EXISTING CONDITIONS MAY HAVE BEEN A CONTRIBUTING FACTOR AS ALL PATIENTS IN THE STUDY HAS UNRESECTABLE MALIGNANT HILAR BILIARY OBSTRUCTION. IT SHOULD ALSO BE NOTED THAT CHOLANGITIS, LIVER ABSCESS AND CHOLECYSTITIS ARE LISTED AS POTENTIAL ADVERSE EVENTS WITHIN THE INSTRUCTIONS FOR USE. ALSO, INFLAMMATION IS LISTED AS AN ADDITIONAL ADVERSE EVENT THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT. WITHIN THE INSTRUCTIONS FOR USE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE STUDY ENDOSCOPIC RE-INTERVENTIONS WERE SUCCESSFUL IN PATIENTS WHO EXPERIENCE RECURRENT BILIARY OBSTRUCTION. 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) # P050017/S002 AND S003. 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¿. BETWEEN MAY AND SEPTEMBER 2013, 13 CONSECUTIVE PATIENTS WITH UMHBO UNDERWENT A SINGLE-STEP SIMULTANEOUS SIDE-BY-SIDE PLACEMENT OF SEMS WITH THE 6-FR DELIVERY SYSTEM. THE TECHNICAL SUCCESS RATE, STENT PATENCY, AND RATE OF COMPLICATIONS WERE EVALUATED FROM THE PROSPECTIVELY COLLECTED DATABASE. MALFUNCTION/INJURY: EARLY COMPLICATIONS: EARLY COMPLICATIONS WERE OBSERVED IN THREE (23%) PATIENTS (=30 DAYS) - SEGMENTAL CHOLANGITIS IN ONE PATIENT AND LIVER ABSCESSES IN TWO PATIENTS LATE COMPLICATIONS: LATE COMPLICATIONS OCCURRED IN TWO (15%) PATIENTS (>30 DAYS - SEGMENTAL CHOLANGITIS IN ONE PATIENT AND CHOLECYSTITIS; ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893253 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN
    893257 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 Unknown Required Intervention