BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VASCULAR

    MDR report key: 2861754 · Received December 7, 2012

    Report

    Report Number
    2134265-2012-07558
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, STENT DEPLOYMENT ISSUES OCCURRED.THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6X61X120 EPIC VASCULAR STENT WAS ADVANCED TO THE TARGET LESION AND DEPLOYED. DURING DEPLOYMENT, THE STENT MOVED FORWARD MISSING THE TARGET AREA. ANOTHER EPIC STENT WAS REQUIRED TO BE DEPLOYED TO COVER THE ENTIRE LESION. THE FINAL RESULT OF THE STENT WAS WELL APPOSED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC¿ VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200066020 15202863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention