BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 8009065 · Received October 26, 2018

    Report

    Report Number
    9612164-2018-02958
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 25, 2018
    Report Date
    February 7, 2019
    Manufacturer
    MEDTRONIC PLC
    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.

    Additional Manufacturer Narrative · 1

    CEC ASSESSED THE EVENT AS RELATED TO THE INDEX DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, A COMPLETE SE STENT WAS USED TO TREAT DISSECTION. APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE, REVASCULARIZATION WAS CARRIED OUT IN THE TARGET LESION WITH TWO MEDTRONIC COMPLETE SE STENTS AND ONE NON-MEDTRONIC STENT IMPLANTED. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE AND 24 MONTHS POST REVASCULARIZATION, HIGH GRADED STENOSIS OF SFA RIGHT LEG, TARGET LESION WAS REPORTED. THE PROXIMAL SFA AND POPLITEAL 1 SEGMENT WERE TREATED WITH A NON-MEDTRONIC DEB AND A NON-MEDTRONIC STENT WAS IMPLANTED. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848937 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention