BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE SFA

    MDR report key: 7486038 · Received May 4, 2018

    Report

    Report Number
    9612164-2018-00986
    Event Type
    Death
    Date Received
    May 4, 2018
    Date of Event
    March 24, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, 2 COMPLETE SE STENTS WERE IMPLANTED IN THE PROXIMAL TO DISTAL SFA OF THE LEFT LEG. DURING A REVASCULARISATION OF THE TARGET LESION, 3 IN.PACT PACIFIC DEB AND ONE COMPLETE SE STENT WERE USED. APPROXIMATELY 75 MONTHS POST INDEX PROCEDURE AND 13 MONTHS POST REVASCULARISATION PROCEDURE, THE PATIENT DIED. THE INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO INDEX PROCEDURE, DEVICE OR ANTI PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330648 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| R