BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    MDR report key: 2676133 · Received July 26, 2012

    Report

    Report Number
    3001845648-2012-00036
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 15, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K093619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO EVO-FC-20-25-10-E DEVICES OF LOT NUMBER C751911 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X EVO-FC-20-25-10-E DEVICE OF LOT NUMBER C751911 WAS RETURNED FOR EVAL. THE INTRODUCTION SYSTEM AND THE STENT WERE RETURNED. THE SAFETY WIRE WAS NOT RETURNED AND CONFIRMED TO BE REMOVED. THE CUSTOMER COMPLAINT FORM STATED THAT THE SAFETY WIRE WAS REMOVED ON REACHING THE POINT-OF-NO-RETURN. THE STENT WAS NOT ATTACHED TO THE INTRODUCTION SYSTEM AND NO DAMAGE TO THE STENT WAS NOTED. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT AS THERE WAS NO DAMAGE/MALFUNCTION OBSERVED THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL EVO-FC-20-25-10-E DEVICES, ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE EVO-FC-20-25-10-E DEVICES OF LOT NUMBER C751911 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. NO CORRECTIVE ACTION WARRANTED AT THIS TIME. THE 2 YR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE LIKELIHOOD OF THIS OCCURRENCE IS RARE.

    Description of Event or Problem · 1

    THE STENT WAS RELEASED TO THE POINT OF NO RETURN AND THEY THEN PULLED OUT THE "SECURE WIRE" AND RELEASED THE STENT COMPLETELY. THEN THEY TRIED TO REMOVE THE INTRODUCING SYSTEM. THEY FELT, THAT THE STENT WAS STILL CONNECTED TO THE INTRODUCING SYSTEM. IT WAS NOT POSSIBLE TO REMOVE THE INTRODUCING SYSTEM WITHOUT THE STENT, SO THEY HAD TO REMOVE BOTH. ONLY WITH FORCE, THEY WERE ABLE TO DISCONNECT THE STENT FROM THE INTRODUCING SYSTEM OUTSIDE OF THE BODY. THE POSITIONING WIRE OF THE STENT STUCK BETWEEN THE INNER CATHETER OF THE INTRODUCING SYSTEM AND THE METAL PART. NO SECTION OF THE DEVICE REMAINED IN THE PT'S BODY. THE PT HAS SUFFERED NO ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION ESOPHAGEAL STENT SYSTEM ESW, PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C751911

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK