BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1750136 · Received July 7, 2010

    Report

    Report Number
    2953200-2010-01264
    Event Type
    Injury
    Date Received
    July 7, 2010
    Date of Event
    January 2, 2013
    Report Date
    August 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (OCCLUSION OF SFA ARTERY OR DISTAL VASCULATURE, PAIN LEG/FOOT).

    Description of Event or Problem · 1

    THE PT HAD ONE COMPLETE SE STENT IMPLANTED TO THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROX FOUR DAYS POST INDEX PROCEDURE, THE PT STARTED EXPERIENCING INCREASING DIFFICULTIES WITH RIGHT LOWER EXTREMITY DISCOMFORT AND AT REST ISCHEMIA WAS DIAGNOSED. THE PAIN WAS FAIRLY CONSTANT AND QUITE SEVERE. THE PT UNDERWENT A VASCULAR STUDY WHICH SUGGESTED COMPLETE OCCLUSION OF THE RIGHT SFA. HOSPITALIZATION WAS REQUIRED AND REVASCULARIZATION WAS PERFORMED. THE PT RECOVERED WITH TREATMENT. PT WAS NOT FULLY COMPLIANT WITH MEDICATION POST INDEX PROCEDURE. THE INVESTIGATOR DID NOT INDICATE WHETHER THE REPORTED EVENT WAS RELATED TO THE STUDY STENT/PROCEDURE. COMPLETE SE IS NOT APPROVED FOR USE 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 V00226112

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention CLOPIDOGREL AT TIME OF EVENT.| PT WAS TAKING ASA AND.