BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 8033415 · Received November 2, 2018

    Report

    Report Number
    2183870-2018-00490
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 2, 2018
    Manufacturer
    COVIDIEN
    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 A COMPLETE SE PERIPHERAL STENT WAS IMPLANTED IN THE SFA OF THE RIGHT LEG (R-1) TO TREAT A SCALED PERFORATION. 25 MONTH POST INDEX PROCEDURE TWO COMPLETE SE PERIPHERAL STENT WERE IMPLANTED IN THE SFA OF THE RIGHT LEG (R-1) DURING A REVASCULARIZATION. APPROXIMATELY 49 MONTHS POST INDEX PROCEDURE AND 27 MONTHS POST REVASCULARIZATION, PATIENT SUFFERED A THROMBOTIC OCCLUSION OF ARTERIA FIBULARIS AND ARTERIA TIBIALIS POSTERIOR RIGHT LEG (STUDY LEG). EVENT WAS TREATED WITH A REVASCULARIZATION OF THE PROX SFA AND POPLITEAL 1 USING A NON-MEDTRONIC DEB AND A NON MEDTRONIC STENT. 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
    874481 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention