BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 614910 · Received June 17, 2005

    Report

    Report Number
    3004742046-2005-00099
    Event Type
    Injury
    Date Received
    June 17, 2005
    Report Date
    May 18, 2005
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS, INC.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATION A STENT WAS PLACED DISTALLY IN THE ILIAC (OFF-LABEL). A SECOND STENT WAS ADVANCED TO BE PLACED PROXIMAL, BUT WITH A SLIGHT OVERLAP OF THE FIRST STENT. THIS STENT BECAME HUNG UP ON THE STRUTS OF THE FIRST STENT AND WHEN TRYING TO REPOSITION IT, THE STENT DISLODGED. A 1.5 BALLOON WAS USED TO EXPAND THE STENT AND A LARGER BALLOON WAS USED OT POST-DEPLOY IT. ALTHOUGH THE PHYSICIAN WOULD HAVE LIKED TO BETTER POSITION THE STENT, IT WAS DEPLOYED IN THE INTENDED LESION. THE PHYSICIAN DOES NOT BLAME THE PRODUCT, BUT RATHER THE TECHNIQUE AND ANATOMY. THERE WERE NO PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE GUIDANT ENDOVASCULAR SOLUTIONS, INC. NA 3111151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention