BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 2030372 · Received March 22, 2011

    Report

    Report Number
    9681442-2011-00010
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS BEEN RETURNED AND IS CURRENTLY BEING EVALUATED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT PARTIALLY DEPLOYED IN A HEAVILY CALCIFIED VESSEL PRIOR TO REACHING THE TREATMENT SITE IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DEVICE WAS INSERTED W/O AN INTRODUCER SHEATH. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUD2989

    Patients

    Seq Age Sex Outcome Treatment
    1