BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4615797 · Received March 12, 2015

    Report

    Report Number
    3001845648-2015-00051
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 26, 2015
    Report Date
    February 11, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC RPN IS UNK HOWEVER INFO RECEIVED CONFIRMED THE DEVICE INVOLVED IN THIS EVENT TO BE AN EVOLUTION STENT. METAL STENT/SET (EVOLUTION) DEVICES ARE CURRENTLY MARKETED IN THE US. THEREFORE FDA MDR REPORTING REQUIREMENTS APPLICABLE. INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR THIS PRODUCT FAMILY FOR 'STENT MIGRATION' - NO ADVERSE EFFECTS TO A PT HAVE BEEN REPORTED. POSSIBLE COMMON DEVICE NAMES: ESW, MUM, MQR, FGE. POSSIBLE PMA/510 (K): K080359, K101530, K113510, K121430. THIS IS A GENERAL COMPLAINT IN RELATION TO EVOLUTION DEVICES. THERE WAS NO SPECIFIC LOT OR RPN GIVEN. THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THERE WAS NO SPECIFIC DEVICE INVOLVED IN THIS COMPLAINT AND NO DEVICE WAS RETURNED FOR EVAL, THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER THE INSTRUCTIONS FOR USE, IFU0090-2, MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH EVOLUTION DEVICES. A REVIEW OF THE RELEVANT MFG RECORDS IN RELATION TO THIS COMPLAINT COULD NOT BE PERFORMED AS A SPECIFIC RPN OR LOT NUMBER WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL EVOLUTION DEVICES ARE SUBJECTED TO 100% VISUAL INSPECTION AND FUNCTIONAL CHECK TO ENSURE DEVICE INTEGRITY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DR (B)(6) REPORTED THAT THE EVOLUTION STENTS ARE LIKELY TO MIGRATE LATELY IN GENERAL. NO SPECIFIC CASE OR COMPLAINT. NO DIRECT ACTION TAKEN. NO ADVERSE EFFECTS TO A PT HAVE BEEN REPORTED AS OCCURRING. THE USER HAS CONFIRMED THAT SPECIFIC EVENT DETAILS WILL BE RECORDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171260 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED NONE FAD COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST