BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 11846872 · Received May 19, 2021

    Report

    Report Number
    3001845648-2021-00393
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Report Date
    December 10, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K162717. DEVICE EVALUATION: THE EVO-20-25-12.5-E DEVICE OF LOT NUMBER C1789114 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICES INVOLVED IN THE COMPLAINT WERE EVALUATED IN THE LABORATORY ON 11TH JUNE 2021. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: STENT WAS NOT RETURNED. LOCK WIRE WAS NOT RETURNED. HANDLE WAS ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE. FOLLOWING THE LAB EVALUATION ADDITIONAL INFORMATION WAS REQUESTED TO AID WITH THE INVESTIGATION AND TO DETERMINE IF THE STENT WAS DISCARDED. HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE, THEREFORE IF RECEIVED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. IT MAY BE NOTED THAT SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION TO CLARIFY IF THE LOT NUMBER DETAILED ON THE PACKAGING OF THE DEVICE RETURNED, THE LOT NUMBER IN THE FILE IS C1789114 HOWEVER, THE RETURNED DEVICE LOT NUMBER IS C1661360. A NUMBER OF ATTEMPTS HAVE BEEN MADE TO CLARIFY WHICH LOT NUMBER IS CORRECT HOWEVER, AT THE TIME OF THE INVESTIGATION NO RESPONSE HAS BEEN RECEIVED THEREFORE, THE LOT NUMBER IN THE FILE WILL REMAIN. IF FURTHER INFORMATION IS RECEIVED THE FILE WILL BE RE-OPENED AND UPDATED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-20-25-12.5-E DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-20-25-12.5-E DEVICE OF LOT NUMBER C1789114 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS OCCURRED PREVIOUSLY WITH THIS LOT C1789114 HOWEVER THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT C1789114. THE INSTRUCTIONS FOR USE IFU0061-6 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "WHEN STENT POINT-OF-NO RETURN HAS PASSED, PULL SAFETY WIRE OUT OF DELIVERY HANDLE NEAR WIRE GUIDE PORT". "AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION. ONCE FULL EXPANSION IS CONFIRMED, INTRODUCTION SYSTEM CAN BE SAFELY REMOVED." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. IT IS POSSIBLE THAT THE DISTAL REGION OF INTRODUCER GOT CAUGHT UP ON STENT UPON WITHDRAWAL. SUMMARY: ACCORDING TO THE INITIAL REPORTER, NO CONSEQUENCE ON THE PATIENT. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT - DEVICE EVALUATED: "STENT NOT RETURNED. LOCKWIRE NOT RETURNED. HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PROSTHESIS DID NOT DEPLOY CORRECTLY DURING INSTALLATION. IMPOSSIBLE TO ENLARGE THE PROSTHESIS. IMPOSSIBLE TO LAUNCH THE STENT. ANOTHER STENT WAS FITTED ON THE PATIENT. NO CONSEQUENCE ON THE PATIENT. PRODUCT AVAILABLE F R RETURN. CUSTOMER WOULD LIKE A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749604 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48032 C1789114 10827002480329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown