BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 20901401 · Received December 11, 2024

    Report

    Report Number
    3001845648-2024-00797
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Report Date
    January 24, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 0

    THIS FILE WAS RAISED FROM LITERATURE TO CAPTURE 26 CASES OF ABNORMAL USE - USE OF STENT FOR BENIGN CONDITION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: THE EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED DEVICE OF UNKNOWN RPN AND 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 ASSOCIATED WITH THE FOLLOWING COMPLAINTS: (B)(6) VAN HALSEMA ET AL 2018 - POST-ERCP MILD PANCREATITIS. #1, (B)(6) VAN HALSEMA ET AL 2018 - POST-ERCP SEVERE AND MODERATE PANCREATITIS. #2, (B)(6) VAN HALSEMA ET AL 2018 - FEVER. #3, (B)(6) VAN HALSEMA ET AL 2018 ¿ CHOLANGITIS & CHOLECYSTITIS. #4, (B)(6) VAN HALSEMA ET AL 2018 ¿ STENT MIGRATION. #5, (B)(6) VAN HALSEMA ET AL 2018 ¿ SEVERE PAIN. #6, (B)(6) VAN HALSEMA ET AL 2018 ¿ STENT REOCCLUSION. #7. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL EVOLUTION 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 ANALYSIS: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0062 WHICH INFORMS THE USER ABOUT THE INTENDED USE: "THIS DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE". THERE IS 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: DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE, EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED WAS USED IN THE BENIGN CONDITION. AS PREVIOUSLY NOTED THIS DEVICE INTENDED USE (IFU0062): "THIS DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE". CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE JOURNAL ARTICLE, OFF LABEL USE FOR BENIGN CONDITION HAS BEEN IDENTIFIED. PATIENT OUTCOME IS UNKNOWN. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE, EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED WAS USED IN THE BENIGN CONDITION. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    VAN HALSEMA ET AL 2018 (DIGITAL ACADEMIC REPOSITORY)- ENDOSCOPIC TREATMENT OF STENOSES AND LEAKS IN THE GASTROINTESTINAL TRACT - THE ROLE OF SELF-EXPANDABLE METAL STENTS. BACKGROUND AND AIMS. BILIARY SELF-EXPANDABLE METAL STENT (SEMS) PLACEMENT IS ASSOCIATED WITH A HIGH POST-ERCP PANCREATITIS RISK OF UP TO 18%. WE STUDIED THE ROLE OF ENDOSCOPIC SPHINCTEROTOMY (ES) PRIOR TO BILIARY SEMS PLACEMENT IN THE PREVENTION OF POST-ERCP PANCREATITIS. THIS STUDY WAS DESIGNED AS A SINGLE-CENTER, RETROSPECTIVE COHORT STUDY COMPARING THE CLINICAL OUTCOMES OF BILIARY SEMS PLACEMENT IN PATIENTS WITH AND WITHOUT PRIOR ES. ALL CONSECUTIVE PATIENTS WHO UNDERWENT BILIARY SEMS PLACEMENT BETWEEN JANUARY 2011 AND MARCH 2017 IN THE ACADEMIC MEDICAL CENTER IN AMSTERDAM, THE NETHERLANDS, WERE IDENTIFIED THROUGH AN ELECTRONIC SEARCH IN OUR ENDOSCOPIC DATABASE ENDOBASE (OLYMPUS MEDICAL SYSTEMS, HAMBURG, GERMANY). PATIENTS WERE INCLUDED IF THEY RECEIVED A PRIMARY BILIARY SEMS FOR BENIGN OR MALIGNANT INDICATIONS THROUGH A NATIVE MAJOR DUODENAL PAPILLA. IN TOTAL 366 PATIENTS UNDERWENT PRIMARY BILIARY SEMS PLACEMENT FOR MALIGNANT (92.9%) AND BENIGN (7.1%) INDICATIONS. (REFERENCE (B)(4) FOR OFF LABEL USE) EITHER UNCOVERED SEMSS (UCSEMSS) OR FULLY COVERED SEMSS (FCSEMSS) WERE USED WITH A DIAMETER OF 10 MM, INCLUDING WALLFLEX¿ BILIARY RX STENT (BOSTON SCIENTIFIC CORPORATION, MARLBOROUGH, MA, U.S.) OR EVOLUTION® BILIARY CONTROLLED- RELEASE STENT (COOK MEDICAL, LIMERICK, IRELAND). THIS COMPLAINT WAS OPENED TO CAPTURE 26 CASES X OFF LABEL / ABNORMAL USE. USE OF STENT FOR BENIGN CONDITION. AS PER IFU0056-6 THAT ACCOMPANIES THIS DEVICE "THE DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE."

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596640 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male