BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3999217 · Received July 30, 2014

    Report

    Report Number
    9681442-2014-00112
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    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 US, 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 US 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 THE RADIOPAQUE MARKER RING LOCATED AT THE DISTAL END OF THE OUTER SHEATH OF THE DELIVERY SYSTEM DETACHED DURING DEPLOYMENT OF THE VASCULAR STENT IN THE ILIAC ARTERY LEADING TO A CONSTRUCTION OF THE DEPLOYED STENT BY THE MARKER RING. ATTEMPTS FOR POST-DILATION AND REMOVAL OF THE STENT WERE UNSUCCESSFUL; THEREFORE, AN OPEN SURGICAL INTERVENTION TO REMOVE THE STENT HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446182 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXD3209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention