BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 2912834 · Received January 8, 2013

    Report

    Report Number
    3001845648-2013-00004
    Event Type
    Injury
    Date Received
    January 8, 2013
    Manufacturer
    COOK IRELAND LTD.
    Product Code
    MQR
    PMA / PMN Number
    K113510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE EVO-25-30-8-C DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBERS IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPONENT INVOLVED IN THIS COMPLAINT IS THE COLONIC STENT. PRIOR TO DISTRIBUTION, ALL EVOLUTION COLONIC CONTROLLED-RELEASE STENT SYSTEMS ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE MANUFACTURING RECORDS FOR THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. THE WARNINGS SECTION OF THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE; IFU0052-7 WARNS THE USER AS FOLLOWS: "THE STENT IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. ATTEMPTS TO REMOVE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO SURROUNDING TISSUE OR MUCOSA." THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE LIKELIHOOD OF THIS OCCURRENCE IS RARE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    COLONIC STENT WAS PLACED IN THE COLON OF THE PATIENT. NO ISSUES IN PLACEMENT. STRICTURE OF TUMOR COMPRESSED ON STENT. AFTER 24 HOURS, STENT NEVER FULLY OPENED. DOCTOR HAD ANOTHER ERCP AT A FUTURE DATE AND REMOVED THE STENT AND PLACED A COMPETITOR'S PRODUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY AFTER THE EXPLANT. THE PATIENT DID REQUIRE THE ADDITIONAL PROCEDURE OF HAVING THIS DEVICE EXPLANTED AND HAVING A COMPETITOR'S DEVICE IMPLANTED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10185 EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED STENT, COLONIC METALIC EXPANDABLE MQR COOK IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention