BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 6955324 · Received October 17, 2017

    Report

    Report Number
    9612164-2017-01471
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    August 25, 2017
    Report Date
    November 14, 2017
    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

    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

    INSTENT STENOSIS OCCURRED ONE DAY POST THAT PREVIOUSLY REPORTED. PATIENT ALSO UNDERWENT AMPUTATION OF RIGHT ON THE SAME DATE AS PREVIOUSLY REPORTED PTA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE ONE COMPLETE SE STENT WAS IMPLANTED IN THE RIGHT DISTAL SFA . APPROXIMATELY 49 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED IN-STENT RESTENOSIS IN THE RIGHT DISTAL SFA AND WAS TREATED WITH A PTA BALLOON. EVENT IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734937 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention