BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6543355 · Received May 4, 2017

    Report

    Report Number
    3001845648-2017-00160
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 5, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) # K121430 OF SIMILAR DEVICE. 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. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMERS¿ TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO 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-FC-10-11-6-B DEVICE OF LOT C1209148 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER THE INSTRUCTIONS FOR USE: ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE STENT MIGRATION.¿ FROM THE INFORMATION PROVIDED, THERE HAVE BEEN ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE FOR SEMS REPLACEMENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ALTHOUGH REQUESTED, NO FURTHER DETAILS RECEIVED. STENT MIGRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325729 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1 65 Required Intervention