BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 8211992 · Received January 3, 2019

    Report

    Report Number
    3001845648-2019-00002
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    November 27, 2018
    Report Date
    December 6, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K162717. 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 DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 12 DECEMBER 2018. STENT CROWNS DISTORTED AT DISTAL END. FOLLOWING THE LABORATORY EVALUATION, ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE MEANING OF "DISTAL BELL" . AS PER CUSTOMER TESTIMONY THE "DISTAL BELL" MEANT STENT. PRIOR TO DISTRIBUTION ALL EVO-20-25-8-E 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-20-25-8-E OF LOT NUMBER C1518633 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1518633; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1518633. AS PER THE INSTRUCTIONS FOR USE, IFU0061-5THE PRECAUTIONS FOR THIS DEVICE "A COMPLETE DIAGNOSTIC EVALUATION MUST BE PERFORMED PRIOR TO USE TO DETERMINE PROPER STENT SIZE. STENT SHOULD BE PLACED USING FLUOROSCOPIC MONITORING. " THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0061-5). 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 ATTRIBUTED TO TORTUOUS ANATOMY. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS IDENTIFIED AND VERIFIED IN THE LABORATORY. ACCORDING TO THE INFORMATION REPORTED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE DEVICE HAD AN ISSUE WITH THE RELEASE SYSTEM. THUS THE PRODUCT COULD NOT BE IMPLANTED PROPERLY. EVERYTHING HAS BEEN REMOVED AND STERILIZED. "AS PER COMPLAINT FORM": DURING THE RELEASE OF THE PROSTHESIS THE SAME WAS MOVED PROXIMALLY, NOT OPENING THE DISTAL BELL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. REMOVAL OF THE STENT WITH A FOREIGN BODY FORCEPS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NOTHING. PUT OTHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4103 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48030 C1518633 10827002480305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention