BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1782698 · Received July 28, 2010

    Report

    Report Number
    2953200-2010-01420
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT HAD A COMPLETE SE STENT IMPLANTED TO THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS SUCCESSFULLY DEPLOYED. SEVEN MONTHS POST INDEX PROCEDURE, OCCLUSION OF THE LEFT SFA STENT WAS REPORTED. VASCULAR INTERVENTION WAS PERFORMED AND THE PT RECOVERED WITH TREATMENT. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. COMPLETE SE IS NOT APPROVED FOR IN THE US 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 V00174169

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention