BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS BILIARY STENT

    MDR report key: 1083447 · Received July 29, 2008

    Report

    Report Number
    3005099803-2008-01305
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K896193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE STENT DELIVERY SYSTEM WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. THE BILIARY ENDO UNISTEP PLUS HALO 10MM X 40MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. FOLLOWING STENT DEPLOYMENT, THE PHYSICIAN NOTED THAT THE "DISTAL END TINES WERE UNFRAYED AND POKING IN ALL DIRECTIONS". A SECOND OF THE SAME STENT WAS DEPLOYED WITHIN THE FIRST STENT. THE PT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS BILIARY STENT FGE BOSTON SCIENTIFIC H965430400 9416579

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention