BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 4176548 · Received July 24, 2014

    Report

    Report Number
    9681442-2014-00107
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    April 27, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THAT DURING DEPLOYMENT OF THE VASCULAR STENT IN THE ILIAC ARTERY, THE DEPLOYMENT MECHANISM BECAME BLOCKED WHEN THE STENT WAS BEING RELEASED 1 CM. THE ENTIRE DELIVERY SYSTEM WAS REMOVED AND REPLACED BY ANOTHER VASCULAR STENT THAT WAS DEPLOYED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434650 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVE2600

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR