BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 4745302 · Received April 30, 2015

    Report

    Report Number
    9681442-2015-00036
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE US, 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 US UNDER # P080007. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MFG RELATED FAILURE. THE EVAL OF THE RETURNED SAMPLE CONFIRMED THE REPORTED EVENT. THE INNER CATHETER WAS FOUND TO BE BROKEN AND WAS STUCK ON THE RETURNED GUIDE WIRE. THE STENT WAS NOT RETURNED AS IT REMAINS IN SITU AFTER SUCCESSFUL IMPLANTATION. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. INSUFFICIENT FLUSHING OF THE DEVICE MAY BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT. A HYDROPHILIC-COATED GUIDE WIRE AS USED IN THIS CASE MAY BECOME STUCK IF NOT KEPT WET DURING USE. ON THE BASIS OF INFO AVAILABLE, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. DESPITE GOOD FAITH EFFORTS BY BARD, THE COMPLAINANT WAS UNABLE OR UNWILLING TO PROVIDE ANY PT DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SOME DIFFICULTIES IN ADVANCING THE VASCULAR STENT DELIVERY SYSTEM OVER A HYDROPHILIC-COATED GUIDE WIRE TO THE LESION SITE, THE STENT COULD BE DEPLOYED SUCCESSFULLY IN THE EXTERNAL ILIAC ARTERY. DURING RETRACTION, THE DELIVERY SYSTEM GOT STUCK ON THE GUIDE WIRE AND FORCE NEEDED TO BE APPLIED TO REMOVE IT. AFTER WITHDRAWAL OF THE SYSTEM, THE BREAKAGE OF THE INNER CATHETER WHICH WAS STILL STUCK ON THE GUIDE WIRE WAS NOTICED. THE GUIDE WIRE NEEDED TO BE EXCHANGED BY A NEW GUIDE WIRE FOR POST-DILATION. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285079 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYL0706

    Patients

    Seq Age Sex Outcome Treatment
    1