BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 547099 · Received September 30, 2004

    Report

    Report Number
    2024168-2004-00366
    Event Type
    Injury
    Date Received
    September 30, 2004
    Date of Event
    August 28, 2004
    Report Date
    August 31, 2004
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS THE RECANALIZATION OF A LONG OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY IN A CROSS-OVER TECHNIQUE THROUGH A 7F SHEATH, USING FOUR NITINOL STENTS. THERE WERE NO PROBLEMS IN DELIVERY OF THE STENTS, NOR WERE THERE ANY PROBLEMS NOTICED RETRACTING THE DELIVERY SYSTEMS OF THE STENTS. HOWEVER, AFTER IMPLANTATION OF THE THIRD STENT (ABSOLUTE), THE FRACTURED TIP OF THE DELIVERY SYSTEM WAS NOTICED TO BE STUCK ON THE 'J' OF THE GUIDE WIRE. A COMPLETE RETRIEVAL WAS NOT POSSIBLE, SO THE TIP WAS MANIPULATED INTO THE PELVIC INTERNAL CIRCULATION. (A. ILIACA INTERNAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE GUIDANT VASCULAR INTERVENTION NA 4061551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention| S STENT: ABSOLUTE X2, DYNALINK.