BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 1507655 · Received October 2, 2009

    Report

    Report Number
    9681442-2009-00112
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 4, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    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 DEVICE HAS BEEN RETURNED. THE EVALUATION IS CURRENTLY UNDERWAY. THE 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 TWO VASCULAR STENTS WERE USED IN A KISSING STENT TECHNIQUE IN THE BILATERAL COMMON ILIAC ARTERIES. THE FIRST STENT WAS DEPLOYED WITHOUT ISSUE IN THE RIGHT ILIAC. HOWEVER, DURING PLACEMENT OF THE SECOND STENT IN THE LEFT ILIAC, THE DELIVERY SYSTEM STOPPED DEPLOYING AFTER 2 CM OF THE STENT WAS EXPOSED. THE DELIVERY SYSTEM ALONG WITH THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PT. HOWEVER, 1 CM OF THE STENT DETACHED AND REMAINED ENTANGLED IN THE OTHER STENT. UPON REMOVAL OF THE DELIVERY SYSTEM, THE USER REPORTED THAT A STENT STRUT WAS PERFORATING THROUGH THE DELIVERY SYSTEM SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10 MM STENT WITHOUT ANY PROBLEMS. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK ANSF2846

    Patients

    Seq Age Sex Outcome Treatment
    1