BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E LUMINEXX VASCULAR STENT

    MDR report key: 3070219 · Received April 15, 2013

    Report

    Report Number
    9681442-2013-00039
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P08007/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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 THE REMOVAL OF THE PTA BALLOON CATHETER AFTER POST-DILATION, THE BALLOON SNAGGED ON THE STENT AND SOME OF THE FIBERS ON THE BALLOON BECAME DISRUPTED. REPORTEDLY, THE BALLOON WAS ABLE TO BE REMOVED AND THE STENT PLACEMENT WAS NOT ALTERED BY THE REMOVAL OF THE BALLOON. THERE WAS NO STENT MOVEMENT. THERE WERE NO ADVERSE EFFECTS AND NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162025 E LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWA3620

    Patients

    Seq Age Sex Outcome Treatment
    1