BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4733043 · Received April 24, 2015

    Report

    Report Number
    3001845648-2015-00084
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 27, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PARTICULAR EVO-FC-10-11-6-B DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE U.S. HOWEVER, THIS DEVICE IS CONSIDERED A 'SIMILAR DEVICE' TO OTHER METAL BILIARY STENT/SET DEVICES CURRENTLY REGISTERED FOR SALE IN THE U.S. THE 510(K) NUMBER FOR THESE 'SIMILAR' METAL BILIARY STENT/SET DEVICES IS AS FOLLOWS: K121430. THIS INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR 'DEPLOYMENT ISSUE RESULTING IN EXPOSED STENT REMOVED FROM PATIENT WITH THE DELIVERY SYSTEM' REGARDLESS OF PATIENT OUTCOME. THE DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A FOLLOW UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    COMPLAINT INFORMATION RECEIVED IS AS FOLLOWS: THE PHYSICIAN INSERTED THE STENT ON THE STRICTURE WITHOUT PROBLEM AND WHEN THE STENT WAS AT THE REQUIRED POSITION, THE NURSE PRESSED THE SYSTEM TWICE AND HEARD A STRANGE NOISE. THE DOCTOR COULD SEE ON THE SCREEN THAT THE DELIVERY SYSTEM HAD BROKEN INTO TWO PIECES I.E. BETWEEN THE STENT (TRANSPARENT PART) AND BLUE PART (PUSHER). THE DOCTOR THEN REMOVED THE WHOLE SYSTEM ATTACHED TO THE SCOPE WITHOUT TRAUMATISM FOR THE PATIENT AND REMOVED THE DEVICE FROM THE SCOPE CHANNEL. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED TO HAVE OCCURRED DUE TO THIS INCIDENT. FROM THE INFORMATION RECEIVED, IT IS PRESUMED THAT THE EVOLUTION STENT WAS REMOVED FROM THE PATIENT AS A RESULT OF A DEPLOYMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274263 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1081521

    Patients

    Seq Age Sex Outcome Treatment
    1