BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 15504338 · Received September 29, 2022

    Report

    Report Number
    3001845648-2022-00664
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 26, 2022
    Report Date
    June 21, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE EVALUATION WAS COMPLETED FOR THE EVO-FC-10-11-6-B OF LOT C1947851 WITH AN IMAGE PROVIDED BY THE CUSTOMER ON EVALUATION OF THE IMAGE THE FLEXOR (OUTER CATHETER) WAS OBSERVED TO BE BROKEN BELOW THE ZIP PORT. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS OF LOT NUMBER C1947851 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS OF LOT NUMBER C1947851 CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THE INSTRUCTIONS FOR USE, IFU0062 WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" 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: PER THE COMPLAINT REPORT, "THE SHEATH BROKE WHILE POSITIONING THE PRODUCT". THE EVOLUTION STENT WAS NOT DEPLOYED COMPLETELY AND NOT RELEASED FROM THE DEPLOYMENT SYSTEM. NO FURTHER ELABORATION OF THE MALFUNCTION WAS PROVIDED IN THE COMPLAINT REPORT. UNFORTUNATELY, THE IMAGE QUALITY IS SO POOR, IT IS DIFFICULT TO EVALUATE THE DEVICE, SPECIFICALLY, THE PORTION THAT MALFUNCTION. IT APPEARS THE DISTAL 1 CM OF THE STENT WAS PARTIALLY DEPLOYED WITHIN THE COMMON BILE DUCT, AND THE OUTER SHEATH APPEARS PARTIALLY RETRACTED TO ALLOW THIS PARTIAL DEPLOYMENT. I AM UNCERTAIN BASED ON THE IMAGE IF THE SHEATH HAS SEPARATED OR IF IT WAS STUCK/NOT RETRACTED ANY FURTHER. IF THE SHEATH WAS STUCK, AND WOULD NOT RETRACT ANY FURTHER, THE OPERATOR COULD HAVE TRIED TO RECAPTURE THE STENT AND REDEPLOY IT, AS THE DIRECTIONAL SELECTOR CAN BECOME PARTIALLY DEPRESSED, PREVENTING MOVEMENT IN EITHER DIRECTION. NO COMMENT WAS INCLUDED SUGGESTING THIS WAS ATTEMPTED. THE OPERATOR DID COMMENT ON THE SEVERITY OF THE STRICTURE, BUT THIS SHOULD NOT HAVE IMPEDED THE FUNCTION OF THE DEPLOYMENT MECHANISM. GIVEN THE DESCRIPTION, THIS WAS LIKELY A DEVICE RELATED INCIDENT, ALTHOUGH WITHOUT FURTHER EXPLANATION AND BETTER IMAGING, INCLUDING POTENTIAL PHOTOGRAPHS OF THE BROKEN SHEATH, THIS CANNOT BE CONFIRMED. FORTUNATELY, IT APPEARS THE ENTIRE DEVICE WAS REMOVED, AND A NEW STENT WAS DEPLOYED WITHOUT INCIDENT. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE BROKEN FLEXOR COULD BE ATTRIBUTED POTENTIALLY TO TORTUOUS PATIENT ANATOMY. IT IS POSSIBLE THAT DURING DEPLOYMENT OF THE STENT A TORTUOUS ANATOMY MAY HAVE CAUSED A BUILD-UP OF PRESSURE WHICH MAY HAVE LED TO THE FLEXOR BREAK. IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE STRICTURE WAS VERY SEVERE. THE BROKEN FLEXOR COULD HAVE ATTRIBUTED TO THE ISSUE WITH DEPLOYING THE STENT FULLY FROM THE DEPLOYMENT SYSTEM. CONFIRMATION OF COMPLAINT IS CONFIRMED BASED ON VISUAL INSPECTION. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER THE SHEATH BROKE WHILE POSITIONING THE PRODUCT. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. THE PATIENT¿S OUTCOME IS UNKNOWN, HOWEVER THE PROCEDURE WAS COMPLETED WITH A NEW STENT. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE OF THE BROKEN FLEXOR COULD BE ATTRIBUTED POTENTIALLY TO TORTUOUS PATIENT ANATOMY. IT IS POSSIBLE THAT DURING DEPLOYMENT OF THE STENT A TORTUOUS ANATOMY MAY HAVE CAUSED A BUILD-UP OF PRESSURE WHICH MAY HAVE LED TO THE FLEXOR BREAK. IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE STRUCTURE WAS VERY SEVERE. THE BROKEN FLEXOR COULD HAVE ATTRIBUTED TO THE ISSUE WITH DEPLOYING THE STENT FULLY FROM THE DEPLOYMENT SYSTEM. COMPLAINT IS CONFIRMED BASED ON VISUAL INSPECTION. 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

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 21-JUN-2023

    Description of Event or Problem · 0

    THE SHEATH BROKE WHILE POSITIONING THE PRODUCT. THE EVOLUTION STENT IN QUESTION AS SHOWN IN THE IMAGE BROKE WHEN IT WAS RELEASED, NOT ALLOWING ITS COMPLETE RELEASE. THE PROCEDURE ENDED WITH THE INSERTION OF A NEW STENT AND THE EXAMINATION WAS COMPLETED. THE OPERATING DOCTOR WAS (B)(6). THE POSITION WAS OPTIMAL BUT THE STRICTURE VERY SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700094 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1947851 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown