BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 8783910 · Received July 12, 2019

    Report

    Report Number
    3001845648-2019-00322
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231297
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    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. DEVICE EVALUATION: THE EVO-10-11-8-B DEVICE OF LOT NUMBER C1607712 INVOLVED IN THIS COMPLAINT DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH OPEN, ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 04TH JULY 2019. STENT WAS PARTIALLY DEPLOYED ON RETURN. RED SHUTTLE APPROXIMATELY HALF WAY BACK HANDLE. FLEXOR WAS FOUND TO BE KINKED. LOCK WIRE WAS KINKED IN SAME LOCATION AS FLEXOR. THESE FAILURES IDENTIFIED DURING EVALUATION ARE RELATED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-10-11-8-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. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-8-B DEVICE OF LOT NUMBER C1607712 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 #C1607712; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1607712 THE INSTRUCTIONS FOR USE 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 NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: 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 THAT THE KINK OCCURRED AS THEY WERE LOADING THE DEVICE INTO THE SCOPE SUMMARY: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    NO DEPLOYED DURING USE. WHEN START TO DEPLOYED THE STENT EVERYTHING OK, BUT, WHEN A PART WAS RELEASED MORE OR LESS 1 CM, THE SYSTEM IT WAS BLOCKED AND COULD NOT BE FREED ANYMORE, THE ENTIRE SYSTEM WAS REMOVED AND ANOTHER WAS PLACED, WITHOUT RISK FOR THE PATIENT. DEPLOYED. "AS PER COMPLAINT FORM": WHEN START TO DEPLOYED THE STENT ONLY 0,5-1 CMS DEPLOYED AFTER THEN LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580292 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G23129 C1607712 10827002231297

    Patients

    Seq Age Sex Outcome Treatment
    1