BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3784833 · Received February 20, 2014

    Report

    Report Number
    9681442-2014-00033
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 26, 2014
    Report Date
    January 26, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 HAVE BEEN REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF A VASCULAR STENT IN THE LEFT ILIAC ARTERY, RESISTANCE WAS FELT AND THE DEPLOYMENT COULD NOT BE CONTINUED AFTER THE STENT WAS BEING RELEASED 5 MM. THE ENTIRE DELIVERY SYSTEM WAS REMOVED FROM THE PT AND ANOTHER STENT WAS DEPLOYED SUCCESSFULLY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106600 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVB0216

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR