BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC?

    MDR report key: 3133132 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03638
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 A PERIPHERAL STENTING TREATMENT PROCEDURE, STENT DEPLOYMENT ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10X71X75 EPIC VASCULAR STENT WAS ADVANCED TO THE TARGET LESION IN PREPARATION FOR A KISSING STENT DEPLOYMENT. DURING DEPLOYMENT, THE STENT "JUMPED UP INTO THE AORTA" MISSING THE TARGET AREA. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO ADDITIONAL MEASURES WERE TAKEN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237598 EPIC? CATHETER, BILIARY, DIAGNOSTIC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939054107070 15989846

    Patients

    Seq Age Sex Outcome Treatment
    1