BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 2686195 · Received July 28, 2012

    Report

    Report Number
    9681442-2012-00087
    Event Type
    Malfunction
    Date Received
    July 28, 2012
    Date of Event
    June 22, 2010
    Report Date
    July 1, 2010
    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 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # P080007. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. 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. AS THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT AVAILABLE, NO PRODUCT EVALUATION COULD BE PERFORMED. A CD CONTAINING ANGIOGRAMS AND X-RAYS OF THE PROCEDURE WAS RECEIVED. IT COULD BE IDENTIFIED THAT THE PROXIMAL END OF THE STENT REACHED THE AORTA. CONSIDERING THAT THE BALLOON HAS A LENGTH OF 100 MM (AS REPORTED BY THE CUSTOMER), THE PLACED STENT HAS A LENGTH OF APPROXIMATELY 110 MM. HOWEVER, DUE TO THE LOW RESOLUTION OF THE IMAGES THE STRUT PATTERN COULD NOT BE IDENTIFIED. THEREFORE, THE STRUT PATTERN COULD NOT BE TAKEN INTO CONSIDERATION AND AN ELONGATION OF THE STENT THUS COULD NOT BE IDENTIFIED. BASED ON THE IMAGES REVIEWED AND THE INFORMATION AVAILABLE IT COULD NOT BE CONFIRMED THAT THE STENT BECAME ELONGATED DURING DEPLOYMENT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT WAS ELONGATED AFTER DEPLOYMENT IN THE ILIAC ARTERY. THE STENT WAS PLACED BETWEEN THE EXTERNAL ILIAC ARTERY AND THE COMMON ILIAC ARTERY VIA AN ARM ACCESS. THE USER CHECKED THE STENT POSITION WITH THE MARKERS TO ASSURE IT WAS FAR ENOUGH AWAY FROM THE AORTA BEFORE RELEASING THE STENT; HOWEVER, THE STENT ELONGATED AND THE PROXIMAL END REACHED THE AORTA. ALTHOUGH THE STENT WAS FOUND TO BE ELONGATED, THE STENT PLACEMENT WAS SUCCESSFUL AND IT FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANTA0200

    Patients

    Seq Age Sex Outcome Treatment
    1