BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3912498 · Received May 14, 2014

    Report

    Report Number
    9681442-2014-00081
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CRF 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 TWO VASCULAR STENTS IN THE EXTERNAL ILIAC ARTERY, AFTER THE DEPLOYMENT OF THE SECOND STENT RESISTANCE WAS FELT DURING THE REMOVAL OF THE DELIVERY SYSTEM. AFTER PULLING AND PUSHING THE SYSTEM, IT COULD BE REMOVED WITHOUT RESISTANCE. POST ANGIOGRAPHY SHOWED THAT A PORTION (1-2 CM) OF THE PROXIMAL END OF THE VASCULAR STENT WAS FRACTURED AND REMAINED FLOATING IN THE ARTERY. NO FURTHER PATIENT INJURY WAS REPORTED. THE PATIENT IS BEING MONITORED. THE STENT FRAGMENT WILL BE REMOVED SURGICALLY IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287930 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWE3658

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR