BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿

    MDR report key: 2980828 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01036
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILIAC STENTING TREATMENT PROCEDURE A STENT PLACEMENT ISSUE OCCURRED. THE EPIC STENT WAS ADVANCED TO THE ILIAC ARTERY; HOWEVER, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE MARKERS ON THE STENT UNDER MAGNIFICATION. THE EPIC STENT WAS DEPLOYED IN AN UNEXPECTED POSITION WITHIN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC STENT TO OPEN THE OCCLUSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85682 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054104070 15498064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention