BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 6622679 · Received June 8, 2017

    Report

    Report Number
    9681442-2017-00194
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 9, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. 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 FURTHER PATIENT DETAILS TO BARD. 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.

    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. NO SAMPLE WAS RETURNED. ON THE BASIS OF THE EVALUATION OF THE IMAGES PROVIDED, THE REPORTED STENT EXPANSION FAILURE COULD NOT BE CONFIRMED. THE IMAGES DOCUMENT THAT THE MARKER SECTION WAS NOT FULLY CLOSED AFTER DEPLOYMENT. THE OUTER DIAMETER OF THE OPENED STENT WAS SIMILAR IN OTHER SECTIONS. IMAGES DOCUMENTING THE VESSEL OUTER DIAMETER AND CONDITION PRIOR STENT PLACEMENT WERE NOT PROVIDED. THEREFORE, A DEVICE-RELATED DEFICIENCY COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE REPORTED EVENT OF AN INADEQUATE SELF EXPANSION OF THE STENT MAY BE ASSOCIATED WITH A DIFFICULT VESSEL ANATOMY. AS REPORTED, THE VESSEL WAS CALCIFIED AND THE LESION HAD NOT BEEN PRE-DILATED. AN INCORRECT STENT DEPLOYMENT MAY BE ANOTHER CONTRIBUTING FACTOR TO THE REPORTED EVENT. A TRANSPORTATION OR STORAGE RELATED ISSUE COULD NOT BE VERIFIED. ON THE BASIS OF THE INFORMATION AVAILABLE AND THE EVALUATION OF THE IMAGES PROVIDED, A DEFINITE ROOT CAUSE OF 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." ALSO THE IFU STATES: "ONCE THE MOVING MARKER HAS PASSED THE PROXIMAL END OF THE STENT BY APPROXIMATELY 2 CM, THE STENT IS COMPLETELY DEPLOYED. COMPLETE STENT DEPLOYMENT CAN BE FLUOROSCOPICALLY VISUALIZED WHEN THE RADIOPAQUE MARKERS AT THE PROXIMAL AND DISTAL ENDS OF THE STENT ARE FULLY EXPANDED." IN ADDITION, THE IFU STATES THAT POST-DILATION OF THE STENT WITH AN APPROPRIATELY SIZED BALLOON CATHETER IS LEFT TO THE DISCRETION OF THE TREATING PHYSICIAN AND THAT PRE-DILATION OF THE STRICTURE WITH AN APPROPRIATELY SIZED BALLOON DILATATION CATHETER IS ALSO LEFT TO THE DISCRETION OF THE TREATING PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DID NOT SELF EXPAND AFTER RELEASE IN THE ILIAC ARTERY. A BALLOON CATHETER WAS USED TO EXPAND THE STENT COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DID NOT SELF EXPAND AFTER RELEASE IN THE ILIAC ARTERY. A BALLOON CATHETER WAS USED TO OPEN THE STENT COMPLETELY. REPORTEDLY, THERE WAS NO VESSEL MATERIAL PRESENT PREVENTING THE COMPLETE SELF EXPANSION OF THE STENT. THE VESSEL WAS REPORTED TO BE CALCIFIED AND THE LESION HAD NOT BEEN PRE-DILATED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408392 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANAY2599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention