BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 7279685 · Received February 19, 2018

    Report

    Report Number
    9612164-2018-00372
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    January 18, 2018
    Report Date
    April 9, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CEC HAVE ADJUDICATED THAT THE EVENT IS RELATED TO THE DEVICE BUT NOT THE PROCEDURE OR PACLITAXEL. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT HAD A REVASC OF THE DISTAL SFA OF THE LEFT LEG (L-1) USING A COMPLETE SE STENT AND A NON MDT PTA. APPROXIMATELY 37 MONTHS POST REVASC, THE PATIENT SUFFERED STENOSIS OF THE LEFT SFA TARGET LESION. THIS WAS TREATED WITH A PTA AND DEB OF THE LEFT LEG. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123497 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention