BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 17734587 · Received September 13, 2023

    Report

    Report Number
    3001845648-2023-00696
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 4, 2023
    Report Date
    May 8, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K121430. INVESTIGATION STILL ON GOING. FINAL MDR WITH RESULTS AND CONCLUSIONS WILL BE SUBMITTED WITHIN REQUIRED TIMEFRAME.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C2053010 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE. PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS RETURNED AND DAMAGE ON ONE SIDE OF THE ZIP PORT WAS OBSERVED. SEVERAL ATTEMPTS WERE MADE TO THE CUSTOMER TO ACQUIRE ADDITIONAL INFORMATION BUT NONE HAS BEEN RECEIVED. WITH THE 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 RELEVANT MANUFACTURING RECORDS OF LOT NUMBER C2053010 CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: THE INSTRUCTIONS FOR (IFU0062) WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO" REMOVE STENT DELIVERY SYSTEM FROM PACKAGE AND BACKLOAD DEVICE OVER A PREPOSITIONED WIRE GUIDE, ENSURING THE WIRE GUIDE EXITS CATHETER AT ZIP PORT". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED POTENTIALLY TO DEVICE HANDLING WHEN LOADING THE WIRE GUIDE, AS PER IFU THE USER IS INSTRUCTED TO APPLY A SLIGHT CURVE WAS WITH THE ZIP PORT FACING UPWARDS TO HELP THE WIRE GUIDE TO EASILY EXIT THE ZIP PORT. THERE HAS BEEN SEVERAL ATTEMPTS MADE TO REQUIRE ADDITIONAL INFORMATION. HOWEVER, SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. IT IS POSSIBLE THAT IF A SLIGHT CURVE WAS NOT APPLIED TO THE CATHETER AND THE WIRE GUIDE WOULD NOT EXIT THE ZIP PORT AND SUBSEQUENTLY POSSIBLY CAUSED DAMAGE OBSERVED ON ZIP PORT OBSERVED IN THE PICTURE PROVIDED, HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER THE WIREGUIDE WOULD NOT LOAD ON TO THE DEVICE. CONFIRMED QUANTITY OF 01 USED DEVICE. ACCORDING TO THE INITIAL REPORTER, NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    ADVISE THE WIRE WOULD NOT LOAD THEY TRIED A NUMBER OF TIME.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676649 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C2053010 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown