BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 11789378 · Received May 7, 2021

    Report

    Report Number
    3001845648-2021-00375
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    November 2, 2020
    Report Date
    October 13, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K162717. DEVICE EVALUATION: NOTE THAT THIS FILE IS RELATED TO PR (B)(4) (3001845648-2020-00909) THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED). THE EVO-20-25-10-E DEVICE OF LOT NUMBER C1708721 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS DEVICE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. IF IT IS RETURNED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION EVO-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 CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-20-25-10-E OF LOT NUMBER C1708721 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1708721. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0061-7) STATES THE FOLLOWING: ¿STENT CANNOT BE RETRIEVED AFTER THE DEPLOYMENT THRESHOLD HAS BEEN PASSED¿. THERE IS SUFFICIENT EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR (¿AFTER THE SAFETY WIRE REMOVAL, THE PHYSICIAN STILL TRIED TO RECAPTURE THE STENT¿) WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 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 · 0

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

    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

    AS INSTRUCTED BY THE MANUFACTURE "USER ERROR- AFTER THE SAFETY WIRE REMOVAL, THE PHYSICIAN STILL TRIED TO RECAPTURE THE STENT." AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691255 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48031 C1708721 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female