BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE SFA

    MDR report key: 8045279 · Received November 7, 2018

    Report

    Report Number
    2183870-2018-00497
    Event Type
    Death
    Date Received
    November 7, 2018
    Date of Event
    May 5, 2018
    Report Date
    November 7, 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

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, ONE COMPLETE SE STENT (6 X 40 MM) WAS IMPLANTED IN THE RIGHT SFA. APPROXIMATELY 42 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED FROM SEVERE HEADACHE AND ASYSTOLE AND DIED THE SAME DAY; THE CAUSE OF DEATH WAS UNKNOWN. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, PROCEDURE OR PACLITAXEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884974 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death