BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC? VASCULAR

    MDR report key: 3910669 · Received July 2, 2014

    Report

    Report Number
    2134265-2014-04110
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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 PREMATURE STENT DEPLOYMENT OCCURRED. A 6X120X120 EPIC VASCULAR STENT DELIVERY SYSTEM WAS BEING ADVANCED OVER A GUIDE WIRE INSIDE THE PATIENT WHEN IT WAS NOTED THAT THE STENT APPEARED TO HAVE BEGUN TO DEPLOY. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT WAS 1-2MM DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386893 EPIC? VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200061220 16816905

    Patients

    Seq Age Sex Outcome Treatment
    1