BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC? VASCULAR

    MDR report key: 4093901 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05483
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 A STENT DEPLOYMENT ISSUE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). A 8X82X120 EPIC¿ VASCULAR STENT WAS ADVANCED AND IMPLANTED IN THE TARGET LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS SHORTENED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT TO COVER THE SHORTENED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571501 EPIC? VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200088020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention