BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 1448998 · Received May 11, 2009

    Report

    Report Number
    9681442-2009-00048
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    March 30, 2009
    Report Date
    April 16, 2009
    Manufacturer
    ANGIOMED GMBH & CO.
    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

    THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A DEVICE PMA P080007 CURRENTLY DISTRIBUTED IN THE U.S. 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 DEVICE REMAINS IMPLANTED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO DEPLOY THE STENT COMPLETELY DURING PLACEMENT. THE TARGET LESION EXTENDED FROM THE LEFT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THERE WAS SOME DIFFICULTY INSERTING A GUIDEWIRE THROUGH THE LESION; HOWEVER, AFTER THE GUIDEWIRE WAS INSERTED, PRE-DILATION WAS PERFORMED WITHOUT ANY PROBLEM. ALTHOUGH, THERE WAS SOME TRACKING DIFFICULTY AT THE LEVEL OF THE DESCENDING AORTA, THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED OVER THE GUIDEWIRE TO THE TARGET LESION. THE USER STARTED TO DEPLOY THE STENT AND THE DISTAL PART OF STENT DEPLOYED WITHOUT PROBLEM. HOWEVER, THE PROXIMAL PART OF THE STENT DID NOT DEPLOY EVEN THOUGH THE MARKERS OF THE OUTER SHEATH WERE RETRACTED PAST THE TANTALUM MARKERS. THE AREA WHERE THE PROXIMAL STENT WAS DEPLOYED WAS NOT WITHIN THE LESION, BUT IN AN ORDINARY BLOOD VESSEL, THUS A BALLOON WITH A SMALLER DIAMETER WAS INSERTED AND THE STENT WAS DEPLOYED. THERE WERE NO FLOW LIMITATIONS AND 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. ANSI2274

    Patients

    Seq Age Sex Outcome Treatment
    1