BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1745777 · Received July 1, 2010

    Report

    Report Number
    2953200-2010-01241
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    August 25, 2010
    Report Date
    April 25, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD ONE COMPLETE SE STENT IMPLANTED TO THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROX ONE MONTH POST INDEX PROCEDURE, DURING A VISIT TO OUT-PATIENT DEPARTMENT, OCCLUSION OF SFA WAS SEEN ON THE SONOGRAPHY. HOSPITALIZATION WAS REQUIRED AND REVASCULARIZATION WAS PERFORMED. THE PATIENT RECOVERED WITH TREATMENT. PT HAD STOPPED TAKING ASA/PLAVIX PRIOR TO THE REPORTED EVENT. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE/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 V00173446

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention UNK.