BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6800463 · Received August 17, 2017

    Report

    Report Number
    3001845648-2017-00343
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 21, 2017
    Report Date
    July 21, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480381
    PMA / PMN Number
    K113510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 PMA/510(K) #K113510 / K163468 WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY; HOWEVER, IT HAS BEEN DEEMED USER ERROR. THERE WAS NO DEFECT WITH THE DEVICE. PRODUCT MANAGER HAS BEEN CONTACT TO REQUEST THAT TRAINING BE PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-25-30-10-C OF LOT NUMBER C1343329 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRIOR TO DISTRIBUTION ALL EVO-25-30-10-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER INSTRUCTIONS FOR USE, ¿STENT SHOULD BE PLACED ENDOSCOPICALLY WITH FLUOROSCOPIC MONITORING." ALSO, ¿CONFIRM DESIRED STENT POSITION FLUOROSCOPICALLY AND DEPLOY STENT BY REMOVING RED SAFETY GUARD FROM THE HANDLE.¿ ¿AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION. ONCE FULL EXPANSION IS CONFIRMED, INTRODUCTION SYSTEM CAN BE SAFELY REMOVED.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE STENT WAS DEPLOYED EXTRALUMINALLY AND WAS RETRIEVED VIA SURGERY. NOTHING REMAINED INSIDE THE PATIENT. THE PHYSICIAN WAS NOT BLAMING THE DEVICE. ADDITIONAL SURGERY WAS PERFORMED ON PATIENT (WHICH WAS PLANNED ANYWAY), BUT NOT RELATED TO STENT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582209 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48038 10827002480381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention