BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 5217207 · Received November 11, 2015

    Report

    Report Number
    9681442-2015-00213
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. DURING THE EVALUATION OF THE RETURNED DEVICE NO DAMAGE OR DEFECT WAS IDENTIFIED WHICH MAY HAVE LED TO THE REPORTED EVENT. BASED ON THE IMAGES PROVIDED, THE REPORTED EVENT COULD BE CONFIRMED. ONE END OF THE STENT DID NOT OPEN IN DIAMETER DUE TO THE RADIOPAQUE STENT MARKERS GETTING CAUGHT WITH EACH OTHER. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE REPORTED EVENT MAY BE ASSOCIATED WITH A DIFFICULT VESSEL ANATOMY. ALSO AN INCORRECT STENT DEPLOYMENT MAY HAVE LED TO THE REPORTED EVENT. THIS KIND OF EVENT ALSO MAY BE RELATED TO TRANSPORTATION OR STORAGE OF THE PRODUCT AS THE DEVICE MAY HAVE BECOME DAMAGED PRIOR USE. ON THE BASIS OF THE INFORMATION AVAILABLE, 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: "COMPLETE STENT DEPLOYMENT CAN BE FLUOROSCOPICALLY VISUALIZED WHEN THE RADIOPAQUE MARKERS AT THE PROXIMAL AND DISTAL ENDS OF THE STENT ARE FULLY EXPANDED."

    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 21CFR 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 FURTHER PATIENT DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT DID NOT EXPAND COMPLETELY POST IMPLANTATION IN THE ILIAC ARTERY FOR TREATMENT OF AN IN-STENT RESTENOSIS. A BALLOON POST-DILATION WAS PERFORMED TO OPEN THE DISTAL PART OF THE VASCULAR STENT AND AN ADDITIONAL STENT WAS PLACED TO KEEP IT OPEN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748732 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYA3535

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention