BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 4346935 · Received December 16, 2014

    Report

    Report Number
    9681442-2014-00150
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 21, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SPECIFICATIONS PRIOR TO SHIPMENT. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE WAS RETURNED. ON THE BASIS OF THE IMAGES PROVIDED, A DEFINITE ASSESSMENT OF THE STENT LENGTH COULD NOT BE PERFORMED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. DURING DEPLOYMENT THERE MAY BE MINIMAL CHANGES IN STENT LENGTH AS STATED IN THE IFU. FURTHERMORE, THE STENT MIGHT HAVE BECOME SHORTENED DUE TO THE ATTEMPT OF MICRO ADJUSTMENTS OR UNINTENTIONAL MOVEMENTS OF THE HANDLE DURING DEPLOYMENT. THE REPORTED APPLICATION REPRESENTS AN OFF-LABEL USE OF THE DEVICE WHICH MAY BE ANOTHER CONTRIBUTING FACTOR TO THE REPORTED EVENT. ON THE BASIS OF THE INFORMATION AVAILABLE AND THE EVALUATION OF THE IMAGES, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL IMPLANTATION OF THE VASCULAR STENT IN THE ILIAC VEIN, IT WAS FOUND THAT THE STENT DID NOT FULLY COVER THE LESION AS IT WAS SHORTER THAN EXPECTED. A PTA WAS PERFORMED AND AN ADDITIONAL STENT WAS PLACED TO COVER THE LESION COMPLETELY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823548 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXA3530

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention