BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 23510900 · Received November 10, 2025

    Report

    Report Number
    3001845648-2025-00576
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    March 10, 2025
    Report Date
    December 19, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. E1 - (B)(6).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE EVOLUTION® BILIARY STENT SYSTEM ¿ PARTIALLY COVERED OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4), AND IT WAS CREATED IN RESPONSE KOHASHI ET AL. THE ANTI-MIGRATION EFFECT OF PARTIALLY COVERED SELF-EXPANDABLE METAL STENTS FOR UNRESECTABLE MALIGNANT DISTAL BILIARY OBSTRUCTION: A MULTICENTER COMPARATIVE STUDY. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE JAPANESE INSERT (C-ES1608Y02) LISTS ¿STENT MIGRATION¿ AS AN ADVERSE EVENT: THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES WERE DUE TO PATIENTS PRE-EXISTING CONDITIONS. ALSO, AS PREVIOUSLY NOTED ¿STENT MIGRATION¿ IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01 X USED DEVICE. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, STENT REPLACEMENT WAS REQUIRED IN THE CASE OF STENT MIGRATION.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT KOHASHI ET AL. THE ANTI-MIGRATION EFFECT OF PARTIALLY COVERED SELF-EXPANDABLE METAL STENTS FOR UNRESECTABLE MALIGNANT DISTAL BILIARY OBSTRUCTION: A MULTICENTER COMPARATIVE STUDY IN THIS STUDY PATIENTS WITH UNRESECTABLE MDBO WHO UNDERWENT PLACEMENT OF PCSEMSS (EVOLUTION BILIARY STENT; COOK IRELAND LTD.) IN ENDOSCOPY UNITS. BOTH STENTS WERE PLACED AT THE BILIARY STRICTURE DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ENDOSCOPIC SPHINCTEROTOMY WAS PERFORMED BEFORE SEMS INSERTION. THE LENGTH OF THE SEMS WAS SELECTED ACCORDING TO THE LENGTH AND LOCATION OF THE BILIARY STRICTURE. THE PROXIMAL END OF THE SEMS WAS PLACED 10 MM BEYOND THE BILIARY STRICTURE AND THE DISTAL END WAS PLACED 10 MM INTO THE DUODENAL LUMEN ACROSS THE PAPILLA. COMPLETE OR PARTIAL MIGRATION CAUSING RECURRENT BILIARY OBSTRUCTION (RBO) CONFIRMED AT RE-INTERVENTION. PATIENT OUTCOME REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4 PATIENT/EVENT INFO - NOTES PCSEMS GROUP = 39 PATIENTS: FCSEMS GROUP = 42 PATIENTS. AGE: MEDIAN 74 YEARS (PCSEMS; RANGE 21¿96) VS MEDIAN 68.5 YEARS (FCSEMS; 44¿90). SEX: PCSEMS 22 MALE (56%) / 17 FEMALE (44%); FCSEMS 22 MALE (52%) / 20 FEMALE (48%).

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615193 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK IRELAND LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention