BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4293345 · Received November 24, 2014

    Report

    Report Number
    3001845648-2014-00258
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 27, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT REGISTERED FOR SALE IN THE US. HOWEVER, INDICATION FOR USE HAS BEEN CONFIRMED AS MALIGNANT. THEREFORE, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL STENT/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US BASED ON THIS MALIGNANT INDICATION. SIMILAR METAL STENT/SETS (EVOLUTION) ARE CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #: K093619, K080359, K101530, K113510, K121430. FDA MDR REPORTING REQUIRED BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR THE STENT NOT EXPANDING AND REMOVAL OF THE STENT (DEPLOYMENT RELATED). ON EVALUATION OF THE RETURNED DELIVERY SYSTEM, IT WAS NOTED THAT THE SAFETY WIRE WAS NOT RETURNED WITH THE DEVICE. THE STENT WAS NOT RETURNED EITHER DETACHED OR ATTACHED TO THE DELIVERY SYSTEM. THE RED SHUTTLE WAS POSITIONED BEYOND THE POINT OF NO RETURN ON THE DEVICE. THERE WAS A KINK NOTED BETWEEN THE TIP AND PERT TUBING. INFORMATION PROVIDED CONFIRMED THAT THE KINK OCCURRED WHEN THE DEVICE WAS BEING PLACED INTO THE BOX FOR RETURN TO GIRL FOR EVALUATION. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. INFORMATION INDICATED THAT THE PATIENT HAD A MALIGNANT TUMOR OF 6 EM. THE COMPLAINT DESCRIPTION INDICATED THAT THE STENT WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE INTRODUCER/DELIVERY SYSTEM AND THAT THE STENT WAS BEING RETURNED NOT ATTACHED TO THE DELIVERY SYSTEM THEREFORE IT COULD BE CONCLUDED THAT THE STENT BECAME DETACHED AFTER IT WAS REMOVED FROM THE PATIENT. AS THE ACTUAL STENT HAS NOT BEEN RETURNED AND ACTUAL USE CONDITIONS COULD NOT BE REPLICATED IN THE LABORATORY WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL EVO-FC-R-20-25-8-E DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS A SPECIFIC CHECK AS PER THE PRODUCTION INSTRUCTION TO DEPLOY THE STENT APPROXIMATELY 50% AND RECAPTURE IT TO ENSURE IT FUNCTIONS CORRECTLY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-R-20-25-8-E DEVICE OF LOT NUMBER C1020999 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. ONCE FULL EXPANSION IS CONFIRMED, THE INTRODUCTION SYSTEM AND WIRE GUIDE CAN BE SAFELY REMOVED." FROM THE INFORMATION PROVIDED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING PLACEMENT OF AN EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT- FULLY COVERED DEVICE THE STENT DID NOT FULLY EXPAND AT THE PROXIMAL END AND THE LASSOO LOOP STAYED DOSED. WHEN THE DOCTOR REMOVED THE DELIVERY SYSTEM THE EVOLUTION STENT CAME WITH IT ALSO (BECAUSE THE LASSO LOOP STAYED CLOSED). THE DOCTOR PLACED ANOTHER MANUFACTURERS STENT (B)(4) AND THE PATIENT IS DOING FINE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763126 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C1020999

    Patients

    Seq Age Sex Outcome Treatment
    1