BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 1901140 · Received November 10, 2010

    Report

    Report Number
    9681442-2010-00105
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE DELIVERY SYSTEM HAS BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA#P080007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT ELONGATED. REPORTEDLY, THE STENT WAS DEPLOYED TO TREAT A STENOSED LESION LOCATED BETWEEN THE LEFT COMMON ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY. THE LENGTH OF THE STENT SHOULD HAVE BEEN 6 CM. HOWEVER, UNDER IMAGING, THE STENT LENGTH WAS ESTIMATED TO BE ABOUT 8 CM LONG. A 5X80 MM BALLOON CATHETER WAS INSERTED AND USED TO MEASURE THE LENGTH OF THE STENT, WHICH WAS DETERMINED TO BE ABOUT 8 CM LONG. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK ANTB2706

    Patients

    Seq Age Sex Outcome Treatment
    1