BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 8783897 · Received July 12, 2019

    Report

    Report Number
    3001845648-2019-00321
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    May 16, 2019
    Report Date
    July 12, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K093619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US. THE 510(K) NUMBER PROVIDE IS OF THE DEVICE CONSIDERED 'SIMILAR'. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1596670 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. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 14TH JUNE 2019. NO DEFECT FOUND IN THE LABORATORY, DEVICE FUNCTIONED AS INTENDED. FOLLOWING THE LAB EVALUATION ADDITIONAL INFORMATION WAS REQUESTED TO HELP US GAIN A BETTER INSIGHT AS TO WHAT OCCURRED AND ELABORATE ON QUESTION: WAS THE LOCK WIRE USED AT ANY STAGE? "NOT THEY DIDN¿T USE." PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B 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 AN NONCONFORMANCE CODE (FLEXOR BUNCHING/ BROKEN) WAS NOTED ON THE WORK ORDER, HOWEVER THIS WAS SUBSEQUENTLY SCRAPPED AND WOULD NOT HAVE ATTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1596670 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #C1596670; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1596670. THE INSTRUCTIONS FOR USE IFU0062-5 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IFU0062-5. PRODUCT MANAGER NOTIFIED TO CONSIDER RETRAINING AT THE FACILITY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT ANATOMY, AS THE DEVICE WHEN RETURNED FOR EVALUATION FUNCTIONED AS INTENDED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE PRODUCT DIDN'T WORK CORRECTLY. "AS PER COMPLAINT FORM": WHEN THEY STARTED TO INTRODUCE THE CATHETER IN THE PAPILLA THE METAL WIRE OF THE "GUN" STARTED TO MOVE ALONE AND AFTER DIDN'T WORK CORRECTLY.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED AND EVALUATED ON THE 14-JUN: THE STENT WAS PARTIALLY DEPLOYED ON RETURN. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM¿. THE PRODUCT DIDN'T WORK CORRECTLY "AS PER COMPLAINT FORM": WHEN THEY STARTED TO INTRODUCE THE CATHETER IN THE PAPILLA THE METAL WIRE OF THE "GUN" STARTED TO MOVE ALONE AND AFTER DIDN'T WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580715 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1596670 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1