BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6799840 · Received August 17, 2017

    Report

    Report Number
    3001845648-2017-00335
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    June 28, 2017
    Report Date
    July 19, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    PMA / PMN Number
    K101530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    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) #K101530 / K163468 AN IMAGE OF THE DEVICE WAS PROVIDED FOR REVIEW OF THE RED SHUTTLE DEPLOYMENT MARKER HALF WAY BACK THE HANDLE WITH NO PART OF THE STENT DEPLOYED FROM THE SHEATH. 1 X EVO-22-27-9-D OF LOT NUMBER C1253946 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS NO STENT EXPOSURE FROM THE SHEATH. THE LOCKWIRE & THE RED SAFETY TAB WERE RETURNED BUT NOT IN PLACE. UPON ACTUATING THE HANDLE DEPLOYMENT OR RETRACTION WERE NOT POSSIBLE. THE HANDLE OF THE DEVICE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED AND NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP. AS USAGE CONDITIONS CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION ALL EVO-22-27-9-D 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVO-22-27-9-D DEVICE OF LOT C1253946 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE USER ADVANCED THE DEVICE INTO PYLORIC ORIFICE AND BEGAN TO DEPLOY IT. REMOVE THE RED SAFETY GUARD FROM THE HANDLE. THE RED MARKER ON TOP OF INTRODUCER WORKED WELL, BUT THE STENT DIDN'T DEPLOY AT ALL. PUSH THE BUTTON TO RECAPTURE MODE. THEN THEY PULLED SAFETY WIRE OUT OF DELIVERY HANDLE, THE STENT STILL COULD NOT DEPLOY. WITHDRAW THE DEVICE AND REPLACE THE SAME MODEL OF DEVICE TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582173 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR