BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 8068453 · Received November 14, 2018

    Report

    Report Number
    3001845648-2018-00529
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 14, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002238135
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZILBS-635-8-10 DEVICE OF LOT NUMBER C1484442 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 15 NOVEMBER 2018. THE STENT WAS RETURNED IN THREE PIECES AND THE WIRE GUIDE WAS STUCK INSIDE THE DELIVERY SYSTEM. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS-635-8-10 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR ZILBS-635-8-10 OF LOT NUMBER C1484442 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 EVIDENCE OR NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1484442. IFU REVIEW IT MAY BE NO:TED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THESE METAL BILIARY STENTS ARE NOT INTENDED TO BE REPOSITIONED OR REMOVED AFTER DEPLOYMENT IN THE BILE DUCT. IN CASE OF ACCIDENTAL DEPLOYMENT OR IMPROPER PLACEMENT (IMMEDIATELY FOLLOWING DEPLOYMENT), LEAVE THE STENT IN PLACE.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER RE-POSITIONS THE STENT AFTER DEPLOYMENT HAD COMMENCED WAS IDENTIFIED FROM THE INFORMATION PROVIDED AND DURING THE LABORATORY EVALUATION. IT WAS CONFIRMED THAT THE PHYSICIAN REPOSITIONED THE STENT AFTER DEPLOYMENT HAD COMMENCED CAUSING THE STENT TO FRACTURE INTO MULTIPLE PIECES. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE STENT WAS RETURNED IN MULTIPLE PIECES AND WAS DAMAGED. ACCORDING TO THE INITIAL REPORTER, THE PIECES OF SHREDDED STENT HAD TO BE RETRIEVED FROM THE PATIENT USING A BIOPSY FORCEPS, A SNARE AND AN EXTRACTION BALLOON. ALL OF THE PIECES WERE RETRIEVED AND A BOSTON SCIENTIFIC WALL FLEX UNCOVERED BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS "DURING DEPLOYMENT OF THE STENT, THEY ATTEMPTED TO REPOSITION THE STENT AND THE STENT ENDED UP SHREDDING INTO MULTIPLE PIECES THAT WERE LEFT BEHIND IN THE BILIARY DUCT. AFTER THAT, THEY HAD TO RETRIEVE THE PIECES. THEY USED BIOPSY FORCEPS, A SNARE AND AN EXTRACTION BALLOON. THEY WERE ABLE TO GET ALL OF THE PIECES OUT. THEY ENDED UP PLACING A BOSTON SCIENTIFIC WALL FLEX UNCOVERED BILIARY STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE".

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS "DURING DEPLOYMENT OF THE STENT, THEY ATTEMPTED TO REPOSITION THE STENT AND THE STENT ENDED UP SHREDDING INTO MULTIPLE PIECES THAT WERE LEFT BEHIND IN THE BILIARY DUCT. AFTER THAT, THEY HAD TO RETRIEVE THE PIECES. THEY USED BIOPSY FORCEPS, A SNARE AND AN EXTRACTION BALLOON. THEY WERE ABLE TO GET ALL OF THE PIECES OUT. THEY ENDED UP PLACING A BOSTON SCIENTIFIC WALL FLEX UNCOVERED BILIARY STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909570 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G23813 C1484442 10827002238135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention