BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5483084 · Received March 7, 2016

    Report

    Report Number
    3001845648-2016-00061
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 8, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002551715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PARTICULAR DEVICE [EVO-FC-R-20-25-10-E] IS NOT REGISTERED FOR SALE IN THE US. THIS DEVICE IS CONSIDERED A 'SIMILAR' DEVICE TO METAL STENT/SETS (EVOLUTION) DEVICES IF THE COMPLAINT IS RELATED TO MALIGNANT USE ONLY. INDICATION FOR USE IN THIS INSTANCE HAS BEEN CONFIRMED AS MALIGNANT. FDA MDR REPORTING CRITERIA APPLICABLE FOR THIS EVENT. PMA/510(K)# OF SIMILAR DEVICE: K093619. UPON EVALUATION OF THE RETURNED DEVICE IT WAS NOTED THAT THE SAFETY WIRE WAS NOT PRESENT IN THE DEVICE. THE STENT WAS RETURNED FULLY DEPLOYED FROM THE SYSTEM AND IT WAS NOTED THAT THE PROXIMAL FLANGE WAS NOT OPENED FULLY. THE SUTURES WERE EXAMINED AND WERE OK. A SLIGHT BEND WAS NOTED NEAR THE PEAK. IT IS UNKNOWN WHEN THIS PEAK MAY HAVE OCCURRED. IT MAY HAVE OCCURRED IN TRANSPORTATION UPON RETURN OF THE DEVICE. THE HANDLE WAS ACTUATED AND THE DELIVERY SYSTEM WAS OK. 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 CUSTOMERS TESTIMONY AS THE FAILURE COULD NOT BE REPLICATED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-R-20-25-10-E DEVICE OF LOT NUMBER C1014130 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL EVO-FC-R-20-25-10-E DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT (B)(4). AS PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED OF THE FOLLOWING:¿CONFIRM DESIRED STENT POSITION FLUOROSCOPICALLY AND TO ENABLE STENT DEPLOYMENT REMOVE THE RED SAFETY GUARD FROM THE HANDLE. CONTINUE DEPLOYING STENT BY SQUEEZING TRIGGER. NOTE: EACH TRIGGER SQUEEZE WILL DEPLOY STENT BY AN EQUAL AMOUNT. IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT OF NO RETURN, INDICATED WHEN RED MARKER ON TOP OF INTRODUCER HAS PASSED THE POINT OF NO RETURN INDICATOR ON HANDLE.¿ INFORMATION PROVIDED INDICATES THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE USER CONFIRMED THE EVOLUTION STENT RELEASED FROM THE DELIVERY SYSTEM BUT THE PROXIMAL FLANGE DID NOT OPEN. WHILE THE INTRODUCER WAS REMOVED FROM THE PATIENT THE STENT WAS REMOVED AS WELL. AFTER THIS OCCURRENCE THE USER PLACED A DIFFERENT EVOLUTION STENT WHICH OPENED WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140562 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW COOK IRELAND LTD 10827002551715

    Patients

    Seq Age Sex Outcome Treatment
    1