BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 6253277 · Received January 16, 2017

    Report

    Report Number
    3001845648-2017-00011
    Event Type
    Injury
    Date Received
    January 16, 2017
    Date of Event
    December 7, 2016
    Report Date
    January 16, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPECIFIC EVOLUTION DEVICE 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 TO THIS EVENT. PMA/510(K)# OF 'SIMILAR DEVICE: K121430. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMERS¿ TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-8-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 THIS EVO-FC-10-11-8-B DEVICE OF LOT C1159520 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER THE INSTRUCTIONS FOR USE, IFU0062-4: ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE STENT MIGRATION.¿ FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    THIS SPECIFIC EVOLUTION DEVICE 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 TO THIS EVENT. PMA/510(K)# OF 'SIMILAR DEVICE: K121430. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMERS¿ TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-8-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 (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVO-FC-10-11-8-B DEVICE OF LOT C1159520 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER THE INSTRUCTIONS FOR USE, IFU0062-4: ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE STENT MIGRATION.¿ FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO AN ERROR IN THE ORIGINAL REPORT. REPORT WAS INITIALLY SENT AS A 'MALFUNCTION' REPORTABLE EVENT TYPE REPORT HOWEVER AS IT WAS CONFIRMED THAT INTERVENTION WAS REQUIRED AND STENT WAS REMOVED THIS IS BEING CORRECTED TO A 'SERIOUS INJURY' REPORTABLE EVENT TYPE REPORT. INITIAL COMPLAINT REPORTED: IT WAS REPORTED THAT THE EVOLUTION STENT WAS NOTED TO HAVE MIGRATED INSIDE THE CHOLEDOCHO. THE STENT WAS REMOVED. THE PATIENT DID NOT REQUIRE ANOTHER STENT. STENT IMPLANT DATE: (B)(6) 2016. STENT EXPLANT: DATE: (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVOLUTION STENT WAS NOTED TO HAVE MIGRATED INSIDE THE CHOLEDOCHO. THE STENT WAS REMOVED. THE PATIENT DID NOT REQUIRE ANOTHER STENT. STENT IMPLANT DATE: (B)(6) 2016. STENT EXPLANT: DATE: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38247 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention