BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED

    MDR report key: 4641460 · Received March 25, 2015

    Report

    Report Number
    3001845648-2015-00058
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 26, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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) # FOR THESE 'SIMILAR' METAL BILIARY STENT/SET DEVICES IS AS FOLLOWS: K121430. THE INFO PROVIDED IS CURRENTLY BEING INVESTIGATED. A F/U MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    ON THE DAY OF THE PROCEDURE ((B)(6) 2015), SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT. THERE WAS NO PRE-STENT DILATION PERFORMED. AN EVOLUTION BILIARY STENT WAS PLACED AT THE INTENDED LOCATION. THE SITE DID NOTE THAT THE STENT WAS HARD TO SEE VIA FLUOROSCOPY. AT THE COMPLETION OF THE PROCEDURE, THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS FLUOROSCOPIC CONFIRMATION OF BILE FLOW. NO ADD'L PROCEDURES WERE PERFORMED. FOUR DAYS POST-PROCEDURE ((B)(6) 2015), TOTAL BILIRUBIN WAS RECORDED AS 7.37 MG/D. FIVE DAYS POST-PROCEDURE ((B)(6) 2015), THE PT EXPERIENCED SIGNS AND SYMPTOMS OF BILIARY OBSTRUCTION. FULL (NO LONGER COVERING LESION) DISTAL STENT MIGRATION WAS CONFIRMED DURING ENDOSCOPY. THE SITE NOTED THE FOLLOWING: "THE STENT IS AGAINST THE WALL OF THE DUODENUM. ATTEMPT FOR CANNULATION BU THE STENT IS LOCATED ENTIRELY UNDER THE STENOSIS. STENT REMOVED WITH A SNARE." FOLLOWING STUDY STENT REMOVAL A NON-STUDY BILIARY STENT WAS PLACED. IT WAS NOTED THAT THIS EVENT WAS NOT RELATED TO THE STUDY PRODUCT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200172 EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED FGE, CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C896704

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention