BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 4093178 · Received August 21, 2014

    Report

    Report Number
    9681442-2014-00119
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 21CFR 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 AND THE PRODUCT WAS FOUND TO HAVE MET ALL SIGNIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED ISSUE. DURING THE EVAL OF THE COMPLAINT SAMPLE, NO DEVICE DEFICIENCY WAS FOUND. IMAGES WERE PROVIDED SHOWING THE IMPLANTED STENT. DUE TO THE POOR RESOLUTION OF THE IMAGES, THE PATTERN OF THE STENT WAS NOT VISIBLE. NO ADEQUATE SEALING INFO WAS PROVIDED MAKING A LENGTH MEASUREMENT IMPOSSIBLE. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATION OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. DURING DEPLOYMENT, THERE MAY BE MINIMAL CHANGES IN STENT LENGTH AS STATED IN THE IFU. ALSO THE STENT MAY BECOME ELONGATED DUE TO THE ATTEMPT OF MICRO ADJUSTMENTS OR AN UNINTENTIONAL MOVEMENT OF THE HANDLE DURING DEPLOYMENT. BASED ON THE INFO AVAILABLE AND THE IMAGES, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. THE IFU ADVISES FOR POTENTIAL LENGTH CHANGE OF THE STENT IN THE TABLE FOR STENT LENGTH CHANGE INFO. ALSO THE IFU INSUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE VASCULAR STENT, UPON POST-DILATION, IT WAS FOUND THAT THE STENT WAS ELONGATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506743 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYA0251

    Patients

    Seq Age Sex Outcome Treatment
    1