BEUDAMED
    FDA Adverse Event Other Summary report: N

    RACER BILIARY STENT SYSTEM

    MDR report key: 515183 · Received March 9, 2004

    Report

    Report Number
    2953200-2004-01062
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    December 10, 2003
    Report Date
    December 10, 2003
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIV.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 5 MM DIAMETER X 18 MM LENGTH RACER BILIARY STENT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 90% STENOSED RENAL ARTERY LESION IN 2003. THE PT'S VESSELS WERE REPORTED TO BE NON-TORTUOUS AND MODERATELY CALCIFIED. THE LESION WAS REPORTED TO HAVE A SLIGHT INFERIOR TAKE-OFF AND THE DEVICE AND THE DEVICE WAS INSERTED BRACHIALLY. THE LESION WAS NOT PRE-DILATED. DURING INFLATION OF THE RACER DELIVERY SYSTEM BALLOON, IT WAS REPORTED THAT THE DISTAL END INFLATED FIRST AND THE STENT MOVED ON THE BALLOON. AFTER DEPLOYMENT WAS COMPLETED THE STENT WAS FOUND TO BE 3 TO 4 MM IN THE OSTIUM OF THE RENAL ARTERY, WHICH WAS NOT THE INTENDED LOCATION. ANOTHER RACER STENT WAS USED TO COVER THE UNTREATED PORTION OF THE LESION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO BE FINE. MEDTRONIC RECEIVED ANGIOGRAPHIC FILMS AND THEIR EVALUATION REVEALED THAT THE PERFORMANCE OF THE RACER STENT SYSTEM DOES NOT APPEAR TO HAVE LEAD TO THE INACCURATE STENT PLACEMENT. IT IS SUGGESTED THAT THE STENT DELIVERY SYSTEM MOVED PROXIMALLY PRIOR TO DEPLOYMENT, LEAVING THE SYSTEM OUTSIDE THE RENAL OSTIUM. THE CAUSE OF THE MOVEMENT OF THE STENT DELIVERY SYSTEM JUST PRIOR TO STENT BEING DEPLOYED CANNOT BE DETERMINED BASED ON THESE FILMS. THE STENT APPEARS TO HAVE DEPLOYED IN THE CORRECT LOCATION OF PLACEMENT CONFIRMED JUST PRIOR TO DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACER BILIARY STENT SYSTEM PERIPHERAL STENT SYSTEM FGE MEDTRONIC AVE PERIPHERAL DIV. XD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention