BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 14565717 · Received June 1, 2022

    Report

    Report Number
    3001845648-2022-00323
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Report Date
    April 28, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717 .THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717. DEVICE EVALUATION: THE EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. RELATED FILES: (B)(4) - USER ERROR (THIS COMPLAINT) (EVO-E-FC). (B)(4) (EMDR 3001845648-2022-00324) - USER ERROR(EVO-E-PC). THIS COMPLAINT WILL CAPTURE THE USER ERROR OF EVO-E-FC DEVICES PLACED WITHOUT FLUOROSCOPY. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVOLUTION BILIARY DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. 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. THE INSTRUCTIONS FOR USE IFU0061 WHICH ACCOMPANIES THIS DEVICE STATES THE FOLLOWING ¿ USING FLUOROSCOPIC GUIDANCE , INTRODUCE AND ADVANCE THE INTRODUCTION SYSTEM IN SHORT INCREMENTS OVER THE PRE-POSITIONED WIRE GUIDE INTO THE ESOPHAGUS IT IS KNOWN THIS DEVICE WAS PLACED WITH FLUOROSCOPY AS PER CUSTOMER FEEDBACK ¿DUE TO LACK OF FLUOROSCOPY FOR VARIOUS REASONS, MOST ESOPHAGEAL PARTIALLY OR FULLY COVERED STENTS IN GREECE (MORE THAN 60%) ARE PLACED WITHOUT FLUOROSCOPY, GUIDED ONLY BY THE ENDOSCOPIC IMAGE AND THE ENDOSCOPE PLACED IN PARALLEL¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE IT IS KNOWN THAT THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. ACCORDING TO THE INFORMATION AVAILABLE THE CUSTOMER PLACED THE STENTS WITHOUT THE USE OF FLUOROSCOPIC GUIDANCE. 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.

    Description of Event or Problem · 0

    I HAVE A TECHNICAL COMMENT - QUESTION, DUE TO LACK OF FLUOROSCOPY FOR VARIOUS REASONS, MOST ESOPHAGEAL PARTIALLY OR FULLY COVERED STENTS IN GREECE (MORE THAN 60%) ARE PLACED WITHOUT FLUOROSCOPY, GUIDED ONLY BY THE ENDOSCOPIC IMAGE AND THE ENDOSCOPE PLACED IN PARALLEL. IN THESE CASES RADIOPAQUE MARKERS ARE USELESS AS THEY CANNOT BE USED¿ WOULDN'T BE POSSIBLE TO PLACE A HIGHLY VISIBLE YELLOW ENDOSCOPIC MARKER DEFINING THE PROXIMAL END OF STENT TO FACILITATE ACCURATE STENT PLACEMENT, LIKE THE ONE WE HAVE IN BILIARY ¿ COLONIC OR DUODENAL LUTION STENTS ESPECIALLY IN OUR FULLY COVERED EVOLUTION ESOPHAGEAL STENTS, THE INTRODUCER PUSHING CATHETER IS EXACTLY THE SAME COLOUR ¿ GREY WITH THE STENT SO IT IS OFTEN VERY DIFFICULT TO DISTINGUISH IN THE ENDOSCOPIC IMAGE WHERE IS THE PROXIMAL END OF STENT. MY CUSTOMERS ARE ASKING FOR IT AND IN MY HUMBLE OPINION (HAVING BEEN PRESENT IN OVER THAN 200 COOK STENT PLACEMENT CASES PROVIDING TECHNICAL SUPPORT) IT WOULD BE EXTREMELY HELPFUL FACILITATING A LOT THE ACCURATE PLACEMENT. AS PER CC FORM: ACTUALLY THIS IS NOT A COMPLAINT, IMPROVEMENT SUGGESTIONS FROM THE DOCTORS WHO PLACE OUR EVOLUTION ESOPHAGEAL STENTS PARTIALLY AND FULLY COVERED ( AND MYSELF BASED IN MY EXPERIENCE IN THE OPERATION ROOM FOR TECHNICAL SUPPORT). IN GREECE FOR VARIOUS REASONS FLUOROSCOPY IS NOT ALWAYS AVAILABLE IN ENDOSCOPY THIS COMPLAINT WILL CAPTURE THE OFF LABEL USE OF EVO-E-FC DEVICES PLACED WITHOUT FLUOROSCOPY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    FINAL REPORT BEING SUBMITTED DUE TO COMPLETE INVESTIGATION ON 28-APR-23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264606 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown