BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3394025 · Received September 10, 2013

    Report

    Report Number
    9681442-2013-00088
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 14, 2013
    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 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 AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIPS PROCEDURE, THE PHYSICIAN USED THE TRIGGER METHOD TO DEPLOY THE STENT BUT AFTER 2 CM HIGH RESISTANCE WAS FELT AND THE PHYSICIAN COULD NOT CONTINUE THE DEPLOYMENT. THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER STENT WAS USED WHICH DEPLOYED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453019 E-LUMINEXX VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWH2522

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR