BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 8292685 · Received January 31, 2019

    Report

    Report Number
    3001845648-2019-00035
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 3, 2019
    Report Date
    January 3, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163468. 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-25-30-10-C DEVICE OF LOT NUMBER C1526544 WAS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT FILE IS DEALING WITH THE STENT MIGRATION. AN ADDITIONAL FILE WAS OPENED TO DEAL WITH THE SECOND ISSUE - THE YELLOW MARKER NOT BEING VISIBLE. AS PER CUSTOMER TESTIMONY STENT PLACEMENT WAS COMPLETE PRIOR TO REMOVAL. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-25-30-10-C DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-25-30-10-C DEVICE OF LOT NUMBER C1526544 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 #C1526544; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1526544. THE INSTRUCTIONS FOR USE IFU0052-10 WHICH ACCOMPANIES POTENTIAL COMPLICATIONS: "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: STENT MIGRATION; STENT OCCLUSION, ULCERATIONS" THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IFU0052-10. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT ANATOMY, AS PER INSTRUCTIONS FOR USE, (IFU0052-10), STENT MIGRATION IS LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER'S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "YELLOW MARKER THAT YOU SHOULD BE ABLE TO SEE ENDOSCOPICALLY DURING PLACEMENT WAS NOT MOVING IN COORDINATION WITH TRIGGER DEPLOYMENT DEVICE. THEY'D NEVER SEEN THAT OCCUR BEFORE. COULDN'T SEE MOVEMENT BETWEEN YELLOW MARKER AND BLUE. AFTER PLACEMENT, STENT MIGRATED AND THEN PHYSICIAN REMOVED. REMOVED COMPLAINT DEVICE PRIOR TO PLACEMENT AND COMPLETED PROCEDURE WITH ANOTHER DEVICE SUCCESSFULLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85069 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48038 C1526544 10827002480381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention