BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX BILIARY STENT

    MDR report key: 3876134 · Received May 20, 2014

    Report

    Report Number
    9681442-2014-00083
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # 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 DURING PLACEMENT OF A BILIARY STENT IN THE BILE DUCT, THE STENT FAILED TO DEPLOY AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. AN ADDITIONAL STENT WAS PLACED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298689 E-LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYA1987

    Patients

    Seq Age Sex Outcome Treatment
    1