BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 11849508 · Received May 19, 2021

    Report

    Report Number
    3001845648-2021-00400
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 21, 2021
    Report Date
    September 10, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1807095 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 03TH JUNE 2021. ON EVALUATION OF THE DEVICE IT WAS OBSERVED THE FLEXOR (CLEAR SECTION) WAS BROKEN. ACTUATION OF HANDLE WAS POSSIBLE BUT UNABLE TO DEPLOY THE STENT DUE TO BREAK. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B 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 EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1807095 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT C1807095 ; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT C1807095. THE INSTRUCTIONS FOR USE IFU0062-5 WHICH ACCOMPANIES THIS DEVICE INCLUDES THE FOLLOWING CONTRADICTIONS ¿INABILITY TO PASS THE WIRE GUIDE OR STENT THROUGH THE OBSTRUCTED AREA.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. IMPRESSION: 1. THE COMPLAINT OF INABILITY TO ADVANCE THE DELIVERY SYSTEM TO ITS INTENDED LOCATION BECAUSE OF DELIVERY SYSTEM FAILURE IS CONFIRMED. 2. THE INNER DELIVERY CATHETER EITHER STRETCHED AND/OR SEPARATED BETWEEN THE LOCKING WIRE AND THE YELLOW MARKER AS IT WAS PUSHED AGAINST A SEVERE BILE DUCT STENOSIS. 3. LOCKING WIRE PERFORATING OF THE SHEATH WOULD HAVE PREVENTED FURTHER ADVANCEMENT EVEN IF THE LESION¿S RESISTANCE WAS OVERCOME. 4. SUCCESSFUL DEPLOYMENT OF A SECOND EVO-FC-10-11-6-B WAS FACILITATED BY THE PRE-DILATION ACHIEVED BY THE FIRST EVO-FC-10-11-6-B. 5. PANCREATIC CANCER IS NOTORIOUSLY FIBROTIC. PRE-IMPLANTATION ANGIOPLASTY CAN FACILITATE STENT INTRODUCTION. THIS IMPRESSION IS RELATED TO THIS COMPLAINT FOR STENT PLACEMENT PROBLEM. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED POTENTIALLY TO TORTUOUS PATIENT ANATOMY. IT IS POSSIBLE THAT DURING DEPLOYMENT TORTUOUS PATH MAY HAVE CAUSED A BUILD-UP OF PRESSURE CAUSING STENT DEPLOYMENT DIFFICULTIES. IT IS KNOWN FROM CUSTOMER FEEDBACK ¿THE BILIARY STENOSIS WAS VERY HARD AND DIFFICULT TO PASS WITH THE STENT SO MORE THAN COMMON FORCE WAS NEEDED. THE RELEASE SYSTEM DIDN'T WORK SO THE STENT WAS REMOVED AND WAS SUBSEQUENTLY POSITIONED AND OTHER (IDENTICAL) STENT IN THE BILIARY TREE.¿ SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT REQUIRED DUE TO DEVICE EVALUATION ON (B)(6) 2021. "FLEXOR BROKEN". IMAGE REVIEW ALSO RECEIVED ON (B)(6) 2021: "THE COMPLAINT OF INABILITY TO ADVANCE THE DELIVERY SYSTEM TO ITS INTENDED LOCATION BECAUSE OF DELIVERY SYSTEM FAILURE IS CONFIRMED. THE INNER DELIVERY CATHETER EITHER STRETCHED AND/OR SEPARATED BETWEEN THE LOCKING WIRE AND THE YELLOW MARKER AS IT WAS PUSHED AGAINST A SEVERE BILE DUCT STENOSIS."

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    STENT PLACEMENT PROBLEM. DURING THE PASSAGE OF THE STENOSIS, THE CATHETER WAS BROKEN BETWEEN THE STENT AND THE YELLOW MARKER. THIS MADE DELIVERY OF THE STENT IMPOSSIBLE. LATER ANOTHER EVOLUTION STENT (SAME STENT) WAS USED WITHOUT ANY PROBLEMS. "AS PER COMPLAINT FORM": AFTER BILIARY CANNULATION UPON THE GUIDEWIRE WAS INTRODUCED THE STENT IN THE BILIARY SYSTEM. THE BILIARY STENOSIS WAS VERY HARD AND DIFFICULT TO PASS WITH THE STENT SO MORE THAN COMMON FORCE WAS NEEDED. THE RELEASE SYSTEM DIDN'T WORK SO THE STENT WAS REMOVED AND WAS SUBSEQUENTLY POSITIONED AND OTHER (IDENTICAL) STENT IN THE BILIARY TREE. THE PATIENT IS A CANDIDATE FOR A BILIARY STENT DUE TO COMPRESSION-RELATED BILE DUCT STENOSIS AS A CONSEQUENCE OF INOPERABLE PANCREATIC CANCER. AN ERCP WAS PERFORMED WITH BILE DUCT CANNULATION AND PLACEMENT OF A WIRE GUIDE IN THE BILE DUCT. CONTRAST IMAGING SHOWED SEVERE STENOSIS IN THE DISTAL THIRD OF THE BILE DUCT. A METAL STENT WAS PLACED USING A GUIDE WIRE. THIS WAS AN EXTREMELY COMPLEX PROCEDURE AS THE STENOSIS WAS PARTICULARLY HARD AND RIGID, MUCH MORE SO THAN NORMAL. THE STENT WAS PLACED IN THE BILE DUCT USING A WIRE GUIDE WITH GREAT DIFFICULTY, HOWEVER UPON RELEASING THE STENT, THE SYSTEM DID NOT WORK (A SMALL PROTRUDING GREEN WIRE IS VISIBLE IN THE IMAGING). THE STENT WAS THEN REMOVED AND AN IDENTICAL ONE WAS PUT IN PLACE (LOT C1803206), WHICH WAS SUCCESSFULLY RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742952 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1807095 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1