BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 19031866 · Received April 3, 2024

    Report

    Report Number
    3001845648-2024-00128
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 5, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717. DEVICE EVALUATION: THE EVO-20-25-10-E DEVICE OF LOT NUMBER C2136159 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH ITS OPENED ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. ON EVALUATION OF THE DEVICE, THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION: STENT RETURNED SEPARATELY. RED SAFETY TAB NOT RETURNED. PROTECTIVE TUBING RETURNED IN PLACE. DIRECTIONAL BUTTON IN DEPLOY POSITION. RED SHUTTLE ON 16TH DIMPLE. SAFETY WIRE NOT RETURNED. FUNCTIONAL INSPECTION: INNER CATHETER EXPOSED ON RETURN. HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE. A DISCREPANCY WAS NOTED BETWEEN THE LOT NUMBER REPORTED ON TRACKWISE AND THE LOT NUMBER ON THE OUTER PACKAGING OF THE RETURNED DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONFIRM THE CORRECT LOT NUMBER WITH NO CONFIRMATION FROM THE CUSTOMER RECEIVED. IT IS LIKELY THAT THE OUTER PACKAGING OF THE COMPLAINT DEVICE WAS DISCARDED, AND ANOTHER OUTER PACKAGING WAS USED FOR RETURNS TRANSPORTATION, THEREFORE INVESTIGATION IS BASED ON LOT NUMBER C2136159, AS REPORTED ON TRACKWISE. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0061) STATES THE FOLLOWING: "CONFIRM DESIRED STENT POSITION FLUOROSCOPICALLY AND DEPLOY STENT BY REMOVING RED SAFETY GUARD FROM THE HANDLE." "CONTINUE DEPLOYING STENT BY SQUEEZING TRIGGER." "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 THE HANDLE HAS PASSED THE POINT-OF-NO-RETURN ON THE HANDLE LABEL." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. FROM THE CUSTOMER TESTIMONY, THE STENT OPENED PREMATURELY IN THE WRONG POSITION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. IT IS POSSIBLE THAT DURING ADVANCEMENT DIFFICULT ANATOMY CAUSED COMPRESSION OF THE OUTER SHEATH WHICH LED TO THE PARTIAL PREMATURE DEPLOYMENT OF THE STENT. FROM THE CUSTOMER TESTIMONY, THE STENT DID NOT DEPLOY PROXIMALLY AT FIRST AND COULD BE REMOVED TOGETHER WITH THE DELIVERY SYSTEM. 03 ATTEMPTS TO GET ADDITIONAL INFORMATION WERE MADE WITH NO ADDITIONAL INFORMATION FROM THE CUSTOMER/REP RECEIVED. SHOULD THE INFORMATION BECOME AVAILABLE, THIS FILE WILL BE RE-OPENED AND INVESTIGATED ACCORDINGLY. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01 X USED DEVICE. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, THE STENT DID NOT DEPLOY PROXIMALLY AT FIRST AND COULD BE REMOVED ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

    Description of Event or Problem · 0

    THE STENT OPENED PREMATURELY AND COMPLETELY IN THE WRONG POSITION, EVEN THOUGH THE MARKING ONLY REACHED HALFWAY ALONG THE SCALE WHEN IT WAS OPENED.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-SEP-2024. DESCRIPTION OF EVENT UPDATED TO INCLUDE "WE THEREFORE COMPLETELY REMOVED THE STENT AS IT DID NOT DEPLOY PROPERLY PROXIMALLY AT FIRST AND INSERTED A NEW ONE." ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728304 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C2136159 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown