BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 22411068 · Received July 7, 2025

    Report

    Report Number
    3001845648-2025-00309
    Event Type
    Injury
    Date Received
    July 7, 2025
    Report Date
    August 13, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE EVO-FC-X-X-X-B WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. 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 (IFU0062) STATES THE FOLLOWING: "ADDITIONAL ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL ¿ BILE DUCT ULCERATION ¿ DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) ¿ FEVER ¿ INFLAMMATION ¿ INGROWTH DUE TO TUMOR OR EXCESSIVE HYPERPLASTIC TISSUE ¿ NAUSEA ¿ OBSTRUCTION OF THE PANCREATIC DUCT ¿ PAIN/DISCOMFORT ¿ PERFORATION ¿ RECURRENT OBSTRUCTIVE JAUNDICE ¿ STENT MIGRATION ¿ STENT MISPLACEMENT ¿ STENT OCCLUSION ¿ TRAUMA TO THE BILIARY TRACT OR DUODENUM ¿ TUMOR OVERGROWTH ¿ VOMITING¿¿. 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 FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL PROCEDURAL COMPLICATIONS OR KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. AS STATED ABOVE, PER THE INSTRUCTIONS FOR USE, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION. CONFIRMATION OF COMPLAINT: 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 THIS FILE CAPTURES X 01 CASE OF STENT MIGRATION. ACCORDING TO THE INITIAL REPORT, THE DOCTOR COMPLAINS THAT THE STENTS HAVE HIGH LEVELS OF MIGRATION BOTH INWARD AND OUTWARD, WHICH REQUIRED SURGICAL INTERVENTION / SECONDARY PROCEDURES.

    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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-AUG-2025.

    Description of Event or Problem · 0

    NEGATIVE FEEDBACK ON THIS GENERAL RANGE OF GOODS, NOT THIS SPECIFIC LOT** DOCTOR COMPLAINS THAT STENTS HAVE HIGH LEVELS OF MIGRATION BOTH INWARD AND OUTWARD, (HE DOESN'T CLARIFY BUT ALL HIS COLLEAGUES AGREE); AFTER SOME DAYS OF IMPLANT THE STENT MIGRATE; THEY ARE NOW USING STENT WITH FLAPS, WHICH DOES NOT MIGRATE." I.E. HANARO-MITECH BCG-08-080-S180 OR BCG-08-060-S180. PATIENT/EVENT INFO - NOTES. HAVE YOU SUBMITTED ANY INDIVIDUAL COMPLAINTS FOR THIS ISSUE BEFORE? NO. DID ANY OF THE EVENT'S RESULT IN PATIENT IMPACT? I.E., SURGICAL INTERVENTION OR SECONDARY PROCEDURES. HOW LONG WERE THE STENT IN PLACE BEFORE THEY MIGRATED? SECONDARY PROCEDURES NEEDED (TO EXTRACT IT AND/OR TO IMPLANT A NEW ONE; THEY NOTICED WHEN THE STENT HAS MIGRATED IS WHEN BILIRUBIN WAS UP BACK AGAIN. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETED? N/A, YES, NO (IF YES, HOW OFTEN WAS THIS COMPLETED?)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897747 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