BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 6053245 · Received October 25, 2016

    Report

    Report Number
    9612164-2016-01118
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    October 13, 2016
    Report Date
    March 13, 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

    PATIENT IS A SMOKER. THE PREVIOUSLY REPORTED STENT OCCLUSION OF THE R SFA WAS TREATED WITH DEB (NON MDT) AND THROMBOLYSIS. THE % STENOSIS AT TIME OF EVENT WAS 100%. EVENT IS RESOLVED. 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

    CEC ADJUDICATED THAT THE PREVIOUSLY REPORTED STENT OCCLUSION OF THE RIGHT SFA WAS THROMBUS. 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

    DURING INDEX PROCEDURE, A COMPLETE SE PERIPHERAL STENT WAS USED TO TREAT A DISSECTION IN THE RIGHT SFA/POPLITEAL. APPROXIMATELY 46 MONTHS POST INDEX PROCEDURE, STENT OCCLUSION OF THE R SFA (R-1) WAS CONFIRMED. A DUPLEX SCAN WAS PERFORMED AND THROMBOLYSIS IS PLANNED. THE EVENT IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704444 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R