BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3633890 · Received January 18, 2014

    Report

    Report Number
    9681442-2013-00133
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Report Date
    November 22, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 GOT HOOKED AT THE TIP OF THE SHEATH OF THE DELIVERY SYSTEM DURING THE STENT DEPLOYMENT PROCESS. THE SHEATH WAS CUT OFF TO COMPLETE THE STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46323 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXC2134

    Patients

    Seq Age Sex Outcome Treatment
    1