BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3231814 · Received July 15, 2013

    Report

    Report Number
    9681442-2013-00073
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P080007/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. NO OTHER COMPLAINT HAS BEEN RECEIVED WITH REGARD TO THIS LOST NUMBER. UPON RECEIPT OF THE SAMPLE, THE INNER CATHETER WAS FOUND TO BE SEPARATED FROM THE DELIVERY SYSTEM. NO MANUFACTURING-RELATED FAILURE THAT COULD HAVE CAUSED THE DETACHMENT OF THE INNER CATHETER WAS IDENTIFIED. NONE OF THE ACCESSORIES WERE PROVIDED FOR EVALUATION. THE RETRACTION WIRE PROTRUDED FROM THE HANDGRIP SINCE THE CUSTOMER USED THE SLIDE MECHANISM TO DEPLOY THE STENT. POSSIBLY THE CUSTOMER WAS CONFUSED ABOUT THIS CHARACTERISTIC AND MISINTERPRETED THIS AS A DEVICE FAILURE. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE DETACHMENT OF THE INNER CATHETER OF THE DELIVERY SYSTEM HAVE BEEN EVALUATED. A GUIDE WIRE MAY BECOME STUCK IN THE DELIVERY SYSTEM IF NOT KEPT WET DURING THE USE. FURTHERMORE, A DIFFICULT PATIENT ANATOMY MAY BE A CONTRIBUTING FACTOR FOR THE DIFFICULTIES IN ADVANCING A GUIDE WIRE. ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU STATES: "PRIOR TO INSERTING THE DELIVERY CATHETER OVER THE GUIDE WIRE, THE SYSTEM MUST BE FLUSHED WITH STERILE SALINE AT THE TWO FEMALE LUER PORTS UNTIL SALINE DRIPS FROM THE DISTAL TIP OF THE CATHETER." IN ADDITION, THE IFU SUFFICIENTLY ADDRESSES THIS POTENTIAL RISK: "SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING THE PROCEDURE, THE ENTIRE SYSTEM (...) SHOULD BE REMOVED AS A SINGLE UNIT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER CATHETER HAD DETACHED FROM THE DELIVERY SYSTEM DURING REMOVAL FROM THE PATIENT AFTER SUCCESSFUL DEPLOYMENT OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326713 E-LUMINEXX VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWK1351

    Patients

    Seq Age Sex Outcome Treatment
    1