BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    MDR report key: 1871021 · Received October 8, 2010

    Report

    Report Number
    3001845648-2010-00018
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE X (B)(4) WAS RETURNED TO COOK (B)(4) FOR EVAL. ONLY THE STENT PORTION OF THE DEVICE WAS RETURNED. THE STENT WAS NOT RETURNED IN ITS ORIGINAL PACKAGING THEREFORE THE LOT NUMBER CANNOT BE CONFIRMED. THE STENT CROWNS WERE KINKED, WHICH COULD HAVE CAUSED THE DIFFICULTY ENCOUNTERED. IT IS NOT POSSIBLE TO DETERMINE THE DEFINITE ROOT CAUSE AS WE ARE UNABLE TO REPLICATE THE CONDITIONS OF USE IN THE LAB. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT AS THERE WERE NO DEVICES REMAINING IN STOCK AT COOK (B)(4). A REVIEW OF THE DEVICE MFG RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ESOPHAGEAL STENT SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE 2-YR COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. THE INSTRUCTIONS FOR USE WARN THE USER THAT THE STENT IS A PERMANENT IMPLANT AND IS NOT INTENDED TO BE REMOVED. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE ESOPHAGEAL MUCOSA. REMOVAL OF THE STENT DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PT IN THIS CASE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED TO IDENTIFY POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE ENDOSCOPE WAS ADVANCED TO THE PROXIMAL END OF THE STENT BECAUSE THE STENT WOULD NOT FULLY OPEN. THE STENT WAS REMOVED FROM THE PT AND A NEW STENT WAS PLACED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION ESOPHAGEAL STENT SYSTEM ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C512529

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention