BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RACER BILIARY STENT SYSTEM

    MDR report key: 572550 · Received February 14, 2005

    Report

    Report Number
    2953200-2005-01031
    Event Type
    Injury
    Date Received
    February 14, 2005
    Date of Event
    January 13, 2005
    Report Date
    January 13, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 5 MM DIAMETER X 18 MM LENGTH RACER STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A STENOSED RIGHT RENAL ARTERY LESION. THE LESION WAS PRE-DILATED WITH A 5.0 X 20 MM BALLOON. VESSEL MORPHOLOGY WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED LESION SITE. AFTER THE STENT WAS DEPLOYED IT WAS REPORTED THAT THE PHYSICIAN USED THE RACER BALLOON TO POST DILATE AND UPON INFLATING THE BALLOON TO 12 ATM THE BALLOON BURST. THE LABEL INDICATES THAT THE RATE OF BURST PRESSURE IS 12 ATMS. IT WAS REPORTED THAT THE PROXIMAL PORTION OF THE BALLOON TRAVELLED TO THE MID-SFA. THE FOLLOWING DAY THE PHYSICIAN BROUGHT THE PT BACK IN FOR ADD'L PROCEDURES..THE PHYSICIAN IMPLANTED A STENT AT THE LOCATION WHERE THE REPORTED PORTION OF THE BALLOON SETTLED AFTER SEPARATING FROM THE STENT DELIVERY SYSTEM, TO ENTRAP THE BALLOON PIECE BETWEEN THE STENT AND THE ARTERY WALL. NO ADD'L SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO BE FINE. MEDTRONIC VASCULAR RECEIVED THE STENT DELIVERY SYSTEM AND EVALUATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACER BILIARY STENT SYSTEM PERIPHERAL STENT SYSTEM FGE MEDTRONIC VASCULAR NA 74952

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention