BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3855477 · Received April 17, 2014

    Report

    Report Number
    9681442-2014-00069
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    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 21CFR 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 ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF A VASCULAR STENT IN THE ILIAC ARTERY, RESISTANCE WAS MET WHEN THE STENT WAS BEING RELEASED 1 CM. THE STENT COULD NOT BE DEPLOYED. THEREFORE, THE DELIVERY SYSTEM WITH THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. NO FURTHER DEVICE WAS USED. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP TREATMENT. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236413 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXC2141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR