BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RACER BILIARY STENT SYSTEM

    MDR report key: 730321 · Received June 28, 2006

    Report

    Report Number
    2953200-2006-00143
    Event Type
    Injury
    Date Received
    June 28, 2006
    Date of Event
    June 19, 2006
    Report Date
    June 19, 2006
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.6.: EVALUATION RESULTS: UNAPPROVED USED OF DEVICE (DEVICE IS INTENDED FOR USE IN THE BILIARY TREE). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE CALCIFICATION AND MODERATE TORTUOSITY). INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). EVALUATION CONCLUSION: DEVICE FAILURE RELATED TO USER HANDLING (UNAPPROVED USE OF DEVICE AND DEVICE IS UNDICATED FOR USE IN THE BILIARY TREE). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT'S CONDITION (MODERATE CALCIFICATION AND MODERATE TORTUOSITY).

    Description of Event or Problem · 1

    A 4 MM DIAMETER X 18 MM LENGTH RACER BILIARY STENT SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT RENAL ARTERY LESION. THE VESSELS WAS MODERATELY CALCIFIED WITH MODERATE TORTUOSITY. IT WAS REPORTED THAT THE PHYSICIAN HAD POSITIONED THE 6 FRENCH RDC GUIDE CATHETER PARALLEL TO THE RENAL ARTERY AND ATTEMPTED TO ADVANCE THE STENT DELIVERY SYSTEM INTO POSITION FOR PLACEMENT. WHILE THE PHYSICIAN WAS ADVANCING THE DELIVERY SYSTEM. THE GUIDEWIRE LOST POSITIONING AND EXITING INTO THE AORTA. THE STENT DELIVERY SYSTEM WAS ADVANCED SIMUTLANEOUSLY AS THE GUIDEWIRE LOST POSITIONING, RESULTING IN THE STENT DELIVERY SYSTEM OUTSIDE OF THE GUIDE CATHETER AND IN THE AORTA. THE PHYSICIAND PULLED THE STENT DELIVERY SYSTEM BACK INTO THE GUIDE CATHETER AND THE STENT HIT THE EDGE OF THE GUIDE CATHETER, STRIPPING THE STENT OFF OF DELIVERY BALLOON PRIOR TO INFLATION. THE STENT DELIVERY SYSTEM, GUIDEWIRE AND GUIDE CATHETER WERE REMOVED FROM THE PATIENT. THE PHYSICIAN CHANGED GUIDE CATHETERS TO AN 8 FRENCH GUIDE CATHETER. THE LOOSE STENT WAS SUCCESSFULLY SNARED FROM THE PATIENTS AORTA VASCULAR. THE STENT AND DELIVERY SYSTEM WERE DISCARDED BY THE USER FACILITY. THE PHYSICIAN IMPLANTED ANOTHER RACER OF THE SAME SIZE WITH SUCCESSFUL RESULTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACER BILIARY STENT SYSTEM BILIARY STENT SYSTEM FGE MEDTRONIC VASCULAR NA 919232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention