BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 6913889 · Received October 4, 2017

    Report

    Report Number
    3001845648-2017-00430
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 5, 2017
    Report Date
    October 5, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K162717. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). 1 X EVO-20-25-12.5-E WAS RETURNED TO (B)(4) FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS FULLY DEPLOYED AND SEPARATED FROM THE DEVICE ON RETURN. THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE FRONT OF THE HANDLE. THE LOCKWIRE AND RED SAFETY TAB WERE NOT RETURNED. IT WAS POSSIBLE TO ACTUATE THE DEVICE FOR DEPLOYMENT/RETRACTION. THERE WERE NO FUNCTIONAL ISSUES NOTED WITH THE DEVICE. THE BLUE SECTION AT THE TIP OF THE SHEATH WAS SEEN TO BE DAMAGED WHICH COULD HAVE BEEN CAUSED WHEN REMOVING THE DEVICE FROM THE PATIENT. CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. AS USAGE CONDITIONS CANNOT BE REPLICATED A DEFINITIVE ROOT CAUSE FOR THE ISSUE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE LASSO LOOP GOT CAUGHT ON THE BILUMEN. FROM THE INFORMATION PROVIDED, 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K162717. (B)(4). EXEMPTION NUMBER: E2016031 . THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: "THE STENT WAS PLACED AT THE DISTAL PORT OF THE ESOPHAGUS, BETWEEN THE PROXIMAL AND DISTAL MARKS. THE STENT WAS RETRACTED AT THE POINT OF NO RETURN. THEN WE PROCEED TO REMOVE THE THREAD. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE STENT WAS PULLED BY IT AND CAME OUT OF THE PATIENT'S MOUTH." THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN REQUESTED: "THE STENT WAS RETRACTED AT THE POINT OF NO RETURN." CAN THIS STATEMENT BE CLARIFIED PLEASE, WERE THEY PAST THE POINT OF NO RETURN AND THE STENT COULDN'T BE RETRACTED OR DID THEY RETRACT THE STENT PRIOR TO THE POINT OF NO RETURN? THE REPORTER PROVIDED THE FOLLOWING RESPONSE: "THE PHYSICIAN MEANT TO SAY 'RELEASED' INSTEAD OF 'RETRACTED'" "THE STENT WAS RELEASED AT THE POINT OF NO RETURN. THE STENT HAS NOT BEEN RETRACTED NEVER." IT WAS ALSO CLARIFIED THAT BY 'THEN WE PROCEED TO REMOVE THE THREAD' THEY MEANT THAT THEY PULLED THE LOCKWIRE. IT HAS BEEN CONFIRMED THAT THE DEVICE INVOLVED IN THIS COMPLAINT IS RETURNING TO COOK IRELAND FOR EVALUATION (SEE E-MAIL ATTACHED); THE DEVICE HAS NOT YET BEEN RECEIVED, HOWEVER, WHEN IT IS RETURNED, THE DEVICE WILL BE EVALUATED AND THE INVESTIGATION WILL BE UPDATED. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE LASSO LOOP GOT CAUGHT ON THE BILUMEN. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-20-25-12.5-E DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER (B)(4) PROCEDURES. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR EVO-20-25-12.5-E REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. FROM THE INFORMATION PROVIDED, THERE IS NO VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED, 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

    FOLLOW-UP REPORT SUBMITTED DUE TO: DEVICE EVALUATION. AS REPORTED TO CUSTOMER RELATIONS: "THE STENT WAS PLACED AT THE DISTAL PORT OF THE ESOPHAGUS, BETWEEN THE PROXIMAL AND DISTAL MARKS. THE STENT WAS RELEASED AT THE POINT OF NO RETURN. THEN WE PROCEED TO REMOVE THE THREAD. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE STENT WAS PULLED BY IT AND CAME OUT OF THE PATIENT'S MOUTH."

    Description of Event or Problem · 1

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE OF "DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM." AS REPORTED TO CUSTOMER RELATIONS: "THE STENT WAS PLACED AT THE DISTAL PORT OF THE ESOPHAGUS, BETWEEN THE PROXIMAL AND DISTAL MARKS. THE STENT WAS RELEASED AT THE POINT OF NO RETURN. THEN WE PROCEED TO REMOVE THE THREAD. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE STENT WAS PULLED BY IT AND CAME OUT OF THE PATIENT'S MOUTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693343 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48032 10827002480329

    Patients

    Seq Age Sex Outcome Treatment
    1