BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    MDR report key: 2500523 · Received March 14, 2012

    Report

    Report Number
    3001845648-2012-00013
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO EVO-20-25-12.5-E DEVICES OF LOT NUMBER C677703 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL THEREFORE, THE CUSTOMER COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE DEVICE IS NOT INTENDED TO BE REMOVED AND IS CONSIDERED A PERMANENT IMPLANT. PRIOR TO DISTRIBUTION, ALL EVO-20-25-12.5-E DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE EVO-20-25-12.5-E DEVICES OF LOT NUMBER C677703 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. THE INSTRUCTIONS FOR USE WARN THE USER THAT MIGRATION IS A POTENTIAL COMPLICATIONS OF THIS PROCEDURE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THERE WERE NO ADVERSE EFFECTS ON THE PT. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE STENT WAS PARTIALLY DEPLOYED AND RECAPTURED 3 TIMES. THE PLACEMENT WAS NEAR THE GASTRO ESOPHAGEAL JUNCTION WITH A DISTAL STRICTURE AND THE DIFFICULTY AROSE ON THE 3RD RECAPTURE. THE TECH WAS NOT ABLE TO RECAPTURE THE STENT FULLY. THE DOCTOR DECIDED TO FULLY DEPLOY THE STENT. THE DOCTOR REPORTED DIFFICULTY PULLING BACK THE INTRODUCER AND REPORTED THE PROXIMAL END OF THE STENT WOULD NOT FULLY OPEN. THE RESULT WAS THAT THE STENT MIGRATED INTO THE STOMACH AND THE STENT HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY 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 C677703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention