BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1040493 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01355
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, 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 A BILE DUCT STENTING PROCEDURE, A STENT DISLODGMENT OCCURRED. THE APPROX 4CM LESION WAS LOCATED IN THE MID-COMMON BILE DUCT. THE PERCENT OF THE STENOSIS OF THE LESION IS UNK. THE EXPRESS BILIARY 8.0 MM X 40MM X 75CM STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY, HOWEVER, ONLY APPROX 20MM OF THE STENT WAS ABLE TO CROSS THE LESION. UPON ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, THE STENT STUCK IN THE LESION WHILE THE DELIVERY SYSTEM WAS WITHDRAWN. THE PHYSICIAN RE-INSERTED THE DELIVERY SYSTEM THROUGH THE LUMEN OF THE STENT AND INFLATED THE SYSTEM TO IMPLANT THE STENT. AN EXPRESS BILIARY 10MM X 40MM X 75CM STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT TO COMPLETE THE PROCEDURE. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION NA 11444328

    Patients

    Seq Age Sex Outcome Treatment
    1