BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4289422 · Received November 12, 2014

    Report

    Report Number
    3001845648-2014-00224
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 14, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS DEVICE IS THEREFORE CONSIDERED 'SIMILAR' TO OTHER METAL STENT/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US BASED ON THIS MALIGNANT INDICATION. NOTE CONFIRMATION OF THIS MALIGNANT INDICATION WAS RECEIVED ON (B)(6) 2014. INITIAL COMPLAINT DETAILS RECEIVED HAD REPORTED THE INDICATION FOR USE WAS BENIGN. SIMILAR METAL STENT/SETS (EVOLUTION) ARE CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510(K)#: K093619, K0803659, K101530, K113510, K121430. INCIDENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR THE STENT NOT FULLY EXPANDING AND REMOVAL OF A PERMANENT STENT (DEPLOYMENT RELATED). ON EVAL OF THE RETURNED STENT, IT WAS NOTED THAT THE STENT SUTURES HAD NOT COMPLETELY OPENED ON THE PROXIMAL END OF THE STENT. THE STENT MEASURED APPROX 12 CM WHICH IS THE CORRECT LENGTH OF STENT FOR THE INTRODUCER. A POSSIBLE CAUSE OF THE SUTURE NOT OPENING COMPLETELY COULD BE IF THE INNER STENT SUTURE KNOT WAS DISTURBED DURING STENT LOADING OF THE EVO-FC-R-20-25-12-E DEVICE. A POSSIBLE CAUSE OF THE STENT NOT RELEASING COULD BE IF THE STENT CROWN HAD BECOME CAUGHT BETWEEN THE BI LUMEN AND PERT COLLAR. THE RELEVANT PERSONNEL HAVE BEEN NOTIFIED AND THIS COMPLAINT WILL BE INCLUDED IN THE NEXT QUALITY AWARENESS TRAINING SESSION CONDUCTED WITH EVOLUTION MFG PERSONNEL. AS ACTUAL USE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THIS COMPLAINT. THE CUSTOMER COMPLAINT COULD BE CONFIRMED AS THE STENT SUTURES HAD NOT COMPLETELY OPENED ON THE PROXIMAL END OF THE STENT. PRIOR TO DISTRIBUTION ALL EVO-FC-R-20-25-12-E DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE IT FUNCTIONS CORRECTLY. AS PER INSTRUCTIONS FOR USE: IF PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS, AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. AS PER IFU, STEP 12 STATES: AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION. ONCE FULL EXPANSION IS CONFIRMED, THE INTRODUCTION SYSTEM AND WIRE GUIDE CAN BE SAFELY REMOVED. THERE WERE NO ADVERSE AFFECTS TO THE PT DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING A LIVE ENDOSCOPY COURSE ((B)(6)), (B)(6) WAS PLACING AN EVO-FC-R-E IN A PT. HE MARKED THE LOCATION OF THE STRICTURE AND PLACED AN INSTINCT SLIP TO IDENTIFY THE STRICTURE. HE THEN PROCEEDED TO PLACE THE INTRODUCER IN THE ESOPHAGUS UNDER FLUOROSCOPY. HE REMOVED THE SAFETY WIRE AT THE APPROPRIATE TIME AND CONTINUED TO DEPLOY THE STENT. AFTER COMPLETE DEPLOYMENT OF THE STENT, HE BEGAN TO REMOVE THE INTRODUCER WHEN HE NOTICED THE STENT WAS ALSO BEING REMOVED WITH THE INTRODUCER. ON CLOSER INSPECTION IT WAS NOTED THAT THE STENT SUTURES HAD NOT COMPLETELY OPENED (INSPECTION OCCURRED WHEN THE STENT WAS REMOVED FROM THE PT BY THE INTRODUCER). (B)(4) REPEATED THE PROCEDURE WITH A NEW EVO-FC-R-E (REFER TO RELATED MDR 3001845648-2014-00225). NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS OCCURRING AS A RESULT OF THIS SPECIFIC INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730708 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW COOK IRELAND LTD C1023109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK