BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLATION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4687238 · Received April 9, 2015

    Report

    Report Number
    3001845648-2015-00076
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 12, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO ANOTHER METAL BILIARY STENT/SET (EVOLUTION) DEVICE CURRENTLY MARKETED IN THE US. A SIMILAR METAL STENT/SET (EVOLUTION) DEVICE IS CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #: K121430. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AND IS BASED ON CUSTOMER TESTIMONY. AS PER THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE BUT ARE NOT LIMITED TO PANCREATITIS". PRIOR TO DISTRIBUTION, ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C897337 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE PATIENT WAS HOSPITALIZED AND RECEIVED ANTIBIOTIC THERAPY. AS PER INFORMATION PROVIDED, THE SITE NOTED THAT THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF THE STUDY DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED AT THE TIME OF ENROLLMENT WITH LOCALLY ADVANCED BILE DUCT CANCER (STAGING: T1 N1 M0) AND WAS NOT UNDERGOING ADJUNCTIVE TUMOR REDUCTION THERAPY. ON THE DAY OF THE PROCEDURE, THE BILIARY STRICTURE MEASURED 1CM AND WAS LOCATED IN THE COMMON BILE DUCT BELOW THE CYSTIC DUCT NO TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. A 10 MM X 6 EM EVOLUTION BILIARY STENT FULLY COVERED WAS THEN PLACED AT THE INTENDED LOCATION. STENT DEPLOYMENT WAS CONSIDERED VERY EASY. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS VISUAL CONFIRMATION OF BILE FLOW. ADDITIONAL PROCEDURES INCLUDED BILIARY BRUSHING AND BIOPSY PRIOR TO PLACEMENT OF THE STUDY STENT. THERE WAS NO PRE OR POST STENT DILATION PERFORMED. ON THE DAY OF PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PANCREATITIS. THE TREATMENT INCLUDED HOSPITALIZATION AND ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234562 EVOLATION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C897337

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention