BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 5942517 · Received September 12, 2016

    Report

    Report Number
    9612164-2016-00957
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    May 31, 2016
    Report Date
    September 2, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    THREE COMPLETE SE ILIAC STENTS WERE USED TO TREAT PERSISTENT RESIDUAL STENOSIS IN THE LEFT SFA . APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED FROM OCCLUSION LEFT FEMOROPOPLITEAL AXE. A TLR WAS CARRIED OUT APPROXIMATELY 8 DAYS LATER USING NON-MEDTRONIC PTA AND STENTING. THROMBOLYSIS WAS ALSO CARRIED OUT. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594068 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention