BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 4092678 · Received August 20, 2014

    Report

    Report Number
    9681442-2014-00117
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 #P080007. 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. THE EVALUATION OF THE RETURNED SAMPLE CONFIRMED THAT THE DEPLOYMENT OF THE STENT BY USING THE TRIGGER MECHANISM WAS NOT POSSIBLE DUE TO THE DETACHMENT OF THE T-LUER ADAPTER FROM THE HANDGRIP. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THIS TYPE OF EVENT MAY BE ASSOCIATED WITH ROUGH HANDLING OF THE DEVICE DURING SHIPMENT OR STORAGE. THIS TYPE OF EVENT ALSO MAY BE CAUSED BY IMPROPER HANDLING OF THE DEVICE DURING PREPARATION OR FLUSHING. ON THE BASIS OF THE EVALUATION OF THE SAMPLE RETURNED AND THE INFO AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY ADDRESSES THE POTENTIAL RISK OF THE USAGE OF A DAMAGED PRODUCT DUE TO SHIPPING OF IMPROPER STORAGE. THE IFU STATES THAT THE SYSTEM SHOULD BE VISUALLY INSPECTED PRIOR TO USE TO VERIFY THAT THE DEVICE HAS NOT BEEN DAMAGED DUE TO SHIPPING OF IMPROPER STORAGE. DAMAGED EQUIPMENT SHOULD NOT BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED. THEREFORE, THE ENTIRE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PLACEMENT OF ANOTHER STENT. NO PATIENT INJURY WAS REPORTED. UPON RECEIPT OF THE COMPLAINT SAMPLE, THE STENT WAS FOUND TO BE PARTIALLY RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500407 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYB1388

    Patients

    Seq Age Sex Outcome Treatment
    1