BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 614806 · Received June 15, 2005

    Report

    Report Number
    6000089-2005-00842
    Event Type
    Injury
    Date Received
    June 15, 2005
    Date of Event
    May 13, 2005
    Report Date
    May 16, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTA / STENTING TREATMENT PROCEDURE, THE UNDERPLOYED EXPRESS BILIARY LD STENT FELL OFF THE BALLOON IN THE PT'S EXTERNAL ILIAC ARTERY DURING ADVANCEMENT. THE PTWAS ASYMPTOMATIC DURING THIS EVENT. THE LESION BEING TREATED WAS CALICIFIED, 75% STENOTIC LESION IN A TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH FOR VASCULAR ACCESS, AND A .035 BENTSON GUIDE WIRE TO CROSS THE LESION. A SNARE WAS USED TO SUCCESSFULLY RETRIVE THE EXPRESS BILIARY STENT. ANOTHER STENT OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETED THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM FGE BOSTON SCIENTIFIC NA 6976692

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention