BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX BILIARY STENT

    MDR report key: 5877872 · Received August 16, 2016

    Report

    Report Number
    9681442-2016-00224
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 19, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT WAS UNABLE TO PROVIDE ANY FURTHER PATIENT DETAILS. 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 # K063532.

    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. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. ON THE BASIS OF THE EVALUATION OF THE RETURNED DEVICE, THE REPORTED BREAKAGE OF THE INNER CATHETER COULD BE CONFIRMED; HOWEVER, THE REPORTED DIFFICULTIES IN REMOVING THE DELIVERY SYSTEM OVER THE GUIDE WIRE COULD NOT BE VERIFIED. THE BREAKAGE OF THE INNER CATHETER IS CONSIDERED A CONSEQUENCE OF THE REPORTED DIFFICULTIES IN REMOVING THE DELIVERY SYSTEM OVER THE GUIDE WIRE. BASED ON THE SAMPLE EVALUATION, THERE IS NO INDICATION FOR A DEVICE-RELATED DEFECT. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THIS TYPE OF EVENT MAY BE ASSOCIATED WITH IMPROPER FLUSHING OF THE DEVICE OR THE USE OF INAPPROPRIATE ACCESSORIES. A HYDROPHILIC-COATED GUIDE WIRE CAN BECOME STUCK IN THE SYSTEM IF NOT KEPT WET THROUGHOUT USE. REPORTEDLY, A HYDROPHILIC-COATED GUIDE WIRE WAS USED DURING THE PROCEDURE. ALSO A DIFFICULT VESSEL ANATOMY OR CHALLENGING STENT PLACEMENT SITE MAY BE CONTRIBUTING FACTORS TO THE REPORTED EVENT. IN THIS CASE, THE TRACKING PATH AND THE LESION SITE WERE REPORTED TO BE CALCIFIED. ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU STATES: "SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING THE PROCEDURE, THE ENTIRE SYSTEM (INTRODUCER SHEATH OR GUIDING CATHETER AND STENT DELIVERY SYSTEM) SHOULD BE REMOVED AS A SINGLE UNIT." AND "AFTER STENT DEPLOYMENT, CAREFULLY WITHDRAW THE DELIVERY SYSTEM FROM THE PATIENT OVER THE GUIDE WIRE. AFTER REMOVING THE DELIVERY SYSTEM, VISUALLY CONFIRM THAT THE ENTIRE STENT DELIVERY SYSTEM HAS BEEN REMOVED." ALSO THE IFU STATES: "THE CATHETER TIP IS TAPERED TO ACCOMMODATE A 0.035" (0.89 MM) GUIDE WIRE. THE GUIDE WIRE EXIT PORT IS LOCATED AT THE PROXIMAL END OF THE DELIVERY SYSTEM. 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." THE REPORTED APPLICATION REPRESENTS AN OFF-LABEL USE OF THE DEVICE. AS PER IFU, THE DEVICE IS INTENDED FOR USE IN THE TREATMENT OF BILIARY STRICTURES RESULTING FROM MALIGNANT NEOPLASMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE DELIVERY SYSTEM AFTER SUCCESSFUL PLACEMENT OF THE BILIARY STENT IN A CALCIFIED LESION IN THE ILIAC ARTERY. AS REPORTED, THE DEPLOYMENT SYSTEM BECAME STUCK AND FORCE WAS NEEDED TO PULL IT OUT. EVENTUALLY, THE PHYSICIAN WAS ABLE TO RETRIEVE THE GUIDE WIRE SUCCESSFULLY BUT IT CAME OUT ALONG WITH A GREEN PIECE OF MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE DELIVERY SYSTEM AFTER SUCCESSFUL PLACEMENT OF THE BILIARY STENT IN A CALCIFIED LESION IN THE ILIAC ARTERY. AS REPORTED, THE DEPLOYMENT SYSTEM BECAME STUCK AND FORCE WAS NEEDED TO PULL IT OUT. EVENTUALLY, THE PHYSICIAN WAS ABLE TO RETRIEVE THE GUIDE WIRE SUCCESSFULLY BUT IT CAME OUT ALONG WITH A GREEN PIECE OF MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531450 E-LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANZF2251

    Patients

    Seq Age Sex Outcome Treatment
    1