BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 2686221 · Received July 28, 2012

    Report

    Report Number
    9681442-2012-00086
    Event Type
    Malfunction
    Date Received
    July 28, 2012
    Date of Event
    June 22, 2010
    Report Date
    July 10, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK, KG.
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE UNITED STATES UNDER# P080007. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MFG ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT AVAILABLE, NO PRODUCT EVAL COULD BE PERFORMED. A CD CONTAINING ANGIOGRAMS AND X-RAYS OF THE PROCEDURE WAS RECEIVED. BASED ON THE STRUT PATTERN, IT COULD BE IDENTIFIED THAT THE STENT BECAME ELONGATED DURING DEPLOYMENT. COMPARING THE PLACE STENT WITH A BALLOON VISIBLE ON THE IMAGES AND CONSIDERING THAT THE BALLOON HAS A LENGTH OF 120 MM (AS REPORTED BY THE CUSTOMER) THE STENT HAS ELONGATED TO A LENGTH OF APPROX 130 MM. IT COULD BE IDENTIFIED THAT THE STENT WAS PLACED OVER THE BIFURCATION OF THE SFA AND THE DEEP FEMORAL ARTERY. BASED ON THE IMAGES REVIEWED AND THE INFO AVAILABLE, IT COULD BE CONFIRMED THAT THE STENT BECAME ELONGATED DURING DEPLOYMENT. ROOT CAUSE COULD BE RELATED TO MANIPULATION OF THE DEVICE AFTER PARTIAL OR FULL DEPLOYMENT. HOWEVER, THE DEFINITIVE ROOT CAUSE IS UNK. THE INSTRUCTIONS FOR USE (IFU) STATES THAT MICRO ADJUSTMENTS ARE NO LONGER POSSIBLE ONCE THE STENT IS PARTIALLY OR FULLY DEPLOYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT WAS ELONGATED AFTER DEPLOYMENT IN THE SUPERFICIAL FEMORAL ARTERY. TWO STENTS WERE PLACED DURING THE PROCEDURE. THE FIRST STENT WAS PLACED WITHOUT ISSUES IN THE DISTAL PART OF THE SFA. THE SECOND STENT, THE SAME LABELLED SIZE, WAS PLACED OVERLAPPING THE FIRST STENT. THIS STENT WAS FOUND TO BE LONGER THAN 120 MM AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-LUMINEXX VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK, KG. ANUA2054

    Patients

    Seq Age Sex Outcome Treatment
    1