BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4790539 · Received May 18, 2015

    Report

    Report Number
    3001845648-2015-00116
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 21, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PARTICULAR EVO-FC-10-11-8-B DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED A "SIMILAR DEVICE" TO OTHER METAL BILIARY STENT/ SET DEVICES CURRENTLY REGISTERING FOR SALE IN THE US. THE 510(K)# FOR THESE "SIMILAR" METAL BILARY STENT/SET DEVICES AS FOLLOWS: K121430. THIS INVESTIGATION ADDRESSES THE STENT MIGRATION EVENT CONFIRMED ON (B)(6) 2015 INVOLVING ECO-FC-10-11-8-B DEVICE OF LOT NUMBER C898480. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS THE DEVICE HAS NOT BEEN RETURNED AND THE CONDITIONS OF USE CANNOT BE REPLICATED IN LABORATORY IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE PATIENT UNDERWENT ENDOSCOPY AND ERCP REVEALED FULL PROXIMAL (UPSTREAM) STENT MIGRATION. FOLLOWING REMOVAL OF THE STUDY STENT, AN UNCOVERED METAL STENT WAS PLACED ACROSS THE STRICTURE. FROM THE INFO PROVIDED, THE PHYSICIAN INDICATED THAT THE EVENT WAS "NOT RELATED" TO PROCEDURE AND "DEFINITELY" DUE TO THE DEVICE. THE INSTRUCTIONS FOR USE, STATES THE FOLLOWING IN THE "PRECAUTIONS" SECTION "PERIODIC EVALUATION OF THE STENT IS ADVISED". PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-8-B DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C898480 REVEALED NO DISCREPANCIES RELATED TO THIS COMPLAINT ISSUE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AN EVO-FC-10-11-8-B STENT WAS PLACED AT THE INTENDED LOCATION. AT THE COMPLETION OF THE PROCEDURE THERE WAS VISUAL CONFIRMATION OF BILE FLOW. NINE DAYS POST-PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPT OF A LOCAL HOSP WITH BLACK STOOLS. THE PATIENT UNDERWENT ENDOSCOPY AND WAS DIAGNOSED WITH A GI BLEED. ON THE SAME DAY BLOOD WORK REVEALED A TOTAL BILIRUBIN OF 7.37 MG/DL AND A HEMOGLOBIN OF 5.7 G/DL. THE SITE NOTED THE FOLLOWING: "ULCER WITH VISIBLE VESSEL, SECONDARY TO STENT RUBBING AGAINST DUODENAL WALL. ULCER WITH VESSEL WAS INJECTED, SCLEROSED AND CLIPPED ON (B)(6) 2015" (THIS INCIDENT IS REPORTED UNDER MDR REF#: 3001845648-2015-00115). SIXTEEN DAYS POST-PROCEDURE, THE PATIENT UNDERWENT ENDOSCOPY AND ERCP REVEALED FULL PROXIMAL (UPSTREAM) STENT MIGRATION. FOLLOWING REMOVAL OF THE STUDY STENT, AN UNCOVERED METAL STENT WAS PLACED ACROSS THE STRICTURE (THIS INCIDENT IS REPORTED UNDER MDR REF#: 3001845648-2015-00116)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321306 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE; CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C8998480

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention