BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3633891 · Received January 18, 2014

    Report

    Report Number
    9681442-2013-00134
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Date of Event
    November 13, 2013
    Report Date
    November 24, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER NUMBER P080007. THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING PROCEDURE THE STENT COULD NOT BE DEPLOYED. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER STENT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. DURING THE EVALUATION OF THE RETURNED COMPLAINT SAMPLE THE STENT WAS FOUND TO BE PARTIALLY RELEASED 1 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46306 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWE1058

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR