BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 5665289 · Received May 18, 2016

    Report

    Report Number
    9681442-2016-00135
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 20, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 EVALUATION OF THE RETURNED DEVICE CONFIRMED THE DETACHMENT OF THE T-LUER ADAPTER FROM THE BLUE SLIDE RESULTING IN THE IMPOSSIBILITY TO DEPLOY THE STENT BY USING THE TRIGGER METHOD. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE DETACHMENT OF THE T-LUER ADAPTER MAY HAVE BEEN CAUSED BY ROUGH HANDLING OF THE DEVICE DURING SHIPPING OR IMPROPER STORAGE, OR DURING PREPARATION (E.G., FLUSHING OF THE SYSTEM). ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU STATES: "VISUALLY INSPECT THE BARD E-LUMINEXX VASCULAR STENT TO VERIFY THAT THE DEVICE HAS NOT BEEN DAMAGED DUE TO SHIPPING OR IMPROPER STORAGE. DO NOT USE DAMAGED EQUIPMENT."

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., 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 U.S. UNDER # P080007. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT WAS UNABLE TO PROVIDE ANY PATIENT DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED IN THE RIGHT ILIAC ARTERY VIA LEFT FEMORAL ACCESS. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319847 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANZI1576

    Patients

    Seq Age Sex Outcome Treatment
    1