BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT SYSTEM

    MDR report key: 2860269 · Received November 1, 2012

    Report

    Report Number
    9681442-2012-00175
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    July 12, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND 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 A VASCULAR STENT IN THE ILIAC ARTERY, THE STENT COULD NOT EASILY EXPAND, TANGLING AT THE PLACEMENT SITE AND RESTRICTING BLOOD FLOW. A STENT FRACTURE WAS ALSO IDENTIFIED AND REPEATED INFLATIONS WERE PERFORMED WITHIN THE TANGLED STENT. FINAL RADIOGRAPHIC IMAGES DEMONSTRATED REDUCED BLOOD FLOW, ALTHOUGH IT WAS IMPROVED AFTER PTA HAD BEEN PERFORMED. FURTHER INFORMATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT SYSTEM NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWA2439

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention