BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5301534 · Received December 16, 2015

    Report

    Report Number
    3001845648-2015-00283
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 17, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS SPECIFIC EVOLUTION DEVICE (EVO-FC-10-11-6-B) IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE. A 'SIMILAR DEVICE' HAS THE FOLLOWING PMA/510(K)#: K121430. STENT MIGRATION CONFIRMED. PATIENT WAS SYMPTOMATIC AND PRESENTED WITH CHOLANGITIS PRIOR TO THIS. ANTIBIOTICS ADMINISTERED. ADDITIONAL NON STUDY STENT PLACED. EVENT MEETS CRITERIA OF FDA MDR SERIOUS INJURY REPORT. MALFUNCTION REPORTING PRECEDENCE FOR 'STENT MIGRATION' ALSO APPLICABLE TO THIS DEVICE FAMILY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS PER ABOVE THE SITE NOTED THE FOLLOWING: ¿STENT MIGRATION (STENT EVACUATED IN STOOLS).¿ AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT CONFIRMED BASED ON THE CUSTOMERS¿ TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO 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 LOT C903727 REVEALED THAT THE EXPIRY DATE FOR THIS DEVICE WAS 05 JULY 2015. AS PER THE INFORMATION PROVIDED THE DATE OF THE PROCEDURE WAS (B)(6) 2015. NO OTHER DISCREPANCIES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE SITE INDICATED THAT THE EVENT WAS UNLIKELY RELATED TO EITHER THE STUDY DEVICE OR PROCEDURE. THE SITE MARKED NO TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE? THE PATIENT CONTINUED TO UNDERGO CHEMOTHERAPY AT EACH OF THE TWO AND THREE MONTH FOLLOW-UP ASSESSMENTS. AS PER THE INSTRUCTIONS FOR USE ¿PRECAUTIONS¿ SECTION: ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION AND/OR MUCOSAL BLEEDING.¿ ALSO, AS PER THE INSTRUCTIONS FOR USE POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE STENT MIGRATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    STUDY: (B)(6) EVOLUTION BILIARY STENT SYSTEM FULLY COVERED; (B)(6) - STENT MIGRATION (FULL, DISTAL) THIS (B)(6) MALE PRESENTED AT THE TIME OF ENROLLMENT WITH A HISTORY OF LOCALLY ADVANCED PANCREATIC CANCER (STAGING: T4 N1 M0). THE PATIENT HAD NOT UNDERGONE TUMOR REDUCTION THERAPY WITHIN 30 DAYS OF THE STUDY PROCEDURE. TOTAL BILIRUBIN COMPLETED ON (B)(6) 2015 (FIVE DAYS PRE-PROCEDURE) WAS 17.43 MG/DL. ON THE DAY OF THE PROCEDURE ((B)(6) 2015) THE BILIARY STRICTURE MEASURED 1 CM IN LENGTH AND WAS LOCATED IN THE COMMON BILE DUCT BELOW THE CYSTIC DUCT. MILD TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT AND NO PRE-STENT DILATION WAS PERFORMED. A 10 MM X 6 CM (C903727) EVOLUTION BILIARY STENT-FULLY COVERED WAS PLACED AT THE INTENDED LOCATION. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS FLUOROSCOPIC CONFIRMATION OF RELIEF OF OBSTRUCTION. NO ADDITIONAL PROCEDURES WERE PERFORMED. THE SITE NOTED THAT THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF THE STUDY DEVICE. TOTAL BILIRUBIN COMPLETED 30 DAYS POST PROCEDURE WAS 2.05 MG/DL. AT 35 DAYS POST-PROCEDURE THE ONE MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD NOT UNDERGONE TUMOR REDUCTION THERAPY SINCE THE LAST CONTACT. AT 64 DAYS POST-PROCEDURE THE TWO MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. AT 92 DAYS POST-PROCEDURE THE THREE MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT ON (B)(6) 2015 (113 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED WITH CHOLANGITIS AND TREATED WITH ANTIBIOTICS. ON (B)(6) 2015 (114 DAYS POST-PROCEDURE) FULL DISTAL STENT MIGRATION WAS DISCOVERED WITH CT. THE SITE NOTED THE FOLLOWING, STENT MIGRATION (STENT EVACUATED IN STOOLS). STUDY: (B)(6) EVOLUTION BILIARY STENT SYSTEM FULLY COVERED. PATIENT: (B)(6). DEVICE LOT #: C903727, DEVICE SERIAL #: NOT APPLICABLE. PRINCIPAL INVESTIGATOR: (B)(4). TREATING PHYSICIAN: (B)(6). RESEARCH COORDINATOR: (B)(6). SITE: (B)(6). THE SITE INDICATED THAT THE EVENT WAS UNLIKELY RELATED TO EITHER THE STUDY DEVICE OR PROCEDURE. THE SITE MARKED NO TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831362 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR