BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 5041967 · Received August 31, 2015

    Report

    Report Number
    3001845648-2015-00163
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 1, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT CURRENTLY MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THE NON EXPANSION OF EVOLUTION STENTS. THIS COMPLAINT IS RELATED TO 1 X EVO-20-25-15-E DEVICE OF LOT#C1084035. 1 X EVO-20-25-15-E DEVICE OF LOT # C1084035 WAS RETURNED FOR EVALUATION. UPON EVALUATION OF THE RETURNED STENT IT WAS NOTED THAT THE STENT WAS RETURNED FULLY DEPLOYED. THERE WAS NO ISSUE NOTED WITH THE STENT. THE PROXIMAL END OF THE STENT WAS FULLY OPENED. THE DEVICE WAS EXAMINED AND NO ISSUE WAS OBSERVED. THE HANDLE WAS ACTUATED AND NO ISSUE WAS NOTED. A DEFINITIVE CAUSE FOR THE CUSTOMER¿S COMPLAINT WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-20-25-15-E DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-20-25-15-E DEVICE OF LOT NUMBER C1084035 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT CURRENTLY MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THE NON EXPANSION OF EVOLUTION STENTS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION AND INVESTIGATION CONCLUSIONS. WHILE DEPLOYING AN EVOLUTION METALLIC STENT, THE PROXIMAL END OF STENT DID NOT OPEN, ALTHOUGH DISTAL END OPENED NORMALLY. STENT WAS RETRIEVED AS PROXIMAL END DID NOT OPEN.

    Description of Event or Problem · 1

    WHILE DEPLOYING AN EVOLUTION METALLIC STENT, THE PROXIMAL END OF STENT DID NOT OPEN, ALTHOUGH DISTAL END OPENED NORMALLY. STENT WAS RETRIEVED AS PROXIMAL END DID NOT OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576638 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR