BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT 6MM X 16MM

    MDR report key: 1951112 · Received December 30, 2010

    Report

    Report Number
    MW5018843
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SELECTIVE LEFT RENAL ANGIOGRAPHY, PTA LEFT RENAL ARTERY USING A 6 X 20 CORDIS AVIATOR BALLOON, ATTEMPTED A COVERED STENT PLACEMENT WITH DISLODGEMENT OF THE STENT IN THE ILIAC ARTERY, REQUIRING STENT PTA OF BARE METAL SELF-EXPANDING 10 X 30 PROTÉGÉ EV3 BARE METAL STENT TO TRAP THE COVERED STENT AGAINST THE WALL DUE TO THE STENT DISLODGEMENT, POST DILATED WITH A 9 X 20 FOX CROSS BALLOON. DIAGNOSIS OR REASON FOR USE: RA STENOSIS/PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST COVERED STENT 6MM X 16MM STENT JCT ATRIUM MEDICAL CORPORATION 1043142708

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention