BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1700869 · Received May 26, 2010

    Report

    Report Number
    2953200-2010-00925
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    November 30, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). OCCLUSION OF SFA ARTERY OR DISTAL VASCULATURE.

    Description of Event or Problem · 1

    PT HAD 1 COMPLETE SE STENT IMPLANTED TO THE LEFT POPLITEAL ARTERY (PPA). THE STENT DEPLOYMENT WAS REPORTED TO BE SUCCESSFUL. EIGHT MONTHS POST INDEX PROCEDURE, THE PT WAS HOSPITALIZED. IN-STENT RESTENOSIS AND DIFFUSE DISEASE OF THE LEFT SUPERFICIAL FEMORAL ARTERY WERE DIAGNOSED. REVASCULARIZATION WAS PERFORMED - STENTING OF THE PROXIMAL PART OF THE SFA AND PPA. THERE WERE NO COMPLICATIONS AND PT WAS DISCHARGED HOME. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS RELATED TO THE STUDY DEVICE/PROCEDURE. COMPLETE SE IS NOT APPROVED FOR USE IN THE UNITED STATES FOR SFA INDICATION, BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY/ILIAC INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR NA V00161758

    Patients

    Seq Age Sex Outcome Treatment
    1 59 DA Male Required Intervention UNK.