BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3878270 · Received February 17, 2014

    Report

    Report Number
    9681442-2014-00029
    Event Type
    Malfunction
    Date Received
    February 17, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 20, 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 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 A VASCULAR STENTING PROCEDURE, HIGH RESISTANCE WAS FELT AND THE VASCULAR STENT COULD NOT BE DEPLOYED AFTER BEING RELEASED 1 CM; THEREFORE, THE ENTIRE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND ANOTHER STENT WAS DEPLOYED SUCCESSFULLY. THE OUTER SHEATH OF THE DELIVERY SYSTEM WAS FOUND TO BE BROKEN AFTER REMOVAL. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99830 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWI2157

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR