BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 11654439 · Received April 13, 2021

    Report

    Report Number
    3001845648-2021-00299
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    September 27, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002238128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K163018. (B)(4). 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-635-6-12 DEVICE OF LOT NUMBER C1781793 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-6-12 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 ZILBS-635-6-12 OF LOT NUMBER C1781793 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1781793. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0065-3). IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE AVAILABLE INFORMATION IN RELATION TO THIS COMPLAINT IS LIMITED. THE DEVICE MAY HAVE FAILED TO DEPLOY FOR MANY REASONS. FOR EXAMPLE, THE DEVICE MAY HAVE BEEN DAMAGED BEFORE BEING USED AS IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO USE. AN INCORRECT SIZE WIRE GUIDE SIZE MAY HAVE USED, OR THE RED SAFETY TAB MAY NOT HAVE BEEN REMOVED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY, THIS MAY HAVE INCREASED DEPLOYMENT FORCES RESULTING IN THE SEPARATION OF THE OUTER SHEATH AND PREVENTING THE STENT FROM DEPLOYING. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. HOWEVER, IT IS KNOWN THAT NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PER REP - (B)(6) 2021 - THE DEVICE DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE. NO ADVERSE EFFECTS TO THE PATIENT REPORTED CURRENTLY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552079 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G23812 C1781793 10827002238128

    Patients

    Seq Age Sex Outcome Treatment
    1