BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 2685165 · Received July 28, 2012

    Report

    Report Number
    9681442-2012-00125
    Event Type
    Malfunction
    Date Received
    July 28, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, 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 UNITED STATES UNDER #P080007. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. THE DEVICE WAS RETURNED AND IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION OF THE DELIVERY SYSTEM, THE STENT RELEASED BY 1 - 2 MM WITH THE SAFETY CLIP STILL IN PLACE. THE SYSTEM WAS REMOVED IMMEDIATELY WITHOUT CAUSING ANY INJURY TO THE PT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PLACING ANOTHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVL3263

    Patients

    Seq Age Sex Outcome Treatment
    1