BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNLINK .035 STENT DELIVERY SYSTEM

    MDR report key: 599797 · Received May 5, 2005

    Report

    Report Number
    3004742046-2005-00039
    Event Type
    Injury
    Date Received
    May 5, 2005
    Date of Event
    April 1, 2005
    Report Date
    April 8, 2005
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS, INC.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUBCLAVIAN (OFF-LABEL USE), USING A 6 F SHEATH (CONTRARY TO IFU). AFTER PRE-DILATION, THE OMNILINK WAS ADVANCED, BUT COULD NOT CROSS THE LESION. AS IT WAS PULLED BACK INTO THE SHEATH, THE STENT DISLODGED FROM THE BALLOON; HOWEVER, REMAINED ON THE GUIDE WIRE. A BALLOON WAS USED IN AN ATTEMPT TO COMPRESS THE BALLOON AGAINST THE VESSEL, BUT WAS UNSUCCESSFUL AND THE STENT SLIPPED OUT OF THE SUBCLAVIN INTO THE AORTA. A SNARE WAS USED TO PULL THE STENT BACK, BUT THE STENT GOT STUCK AT THE GROIN. THE PATIENT HAD A PLANNED SURGERY FOR A CORONARY PROCEDURE, SO THE SURGEON WAS CALLED IN AND SURGICALLY REMOVED THE STENT FROM THE GROIN ARE AT THIS TIME. ANOTHER STENT WAS USED TO STENT THE SUBCLAVIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R