BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 1953483 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00015
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    July 12, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DISLODGEMENT), OTHER (ROOT CAUSE OF TVR UNKNOWN).

    Description of Event or Problem · 1

    ONE COMPLETE SE STENT WAS SUCCESSFULLY IMPLANTED TO THE MID RIGHT SFA DURING THE INDEX PROCEDURE. CLAUDICATION OF LOWER RIGHT EXTREMITIES WAS REPORTED 13 MONTHS POST INDEX PROCEDURE. A CLINICALLY DRIVEN TLR/TVR WAS PERFORMED. INVESTIGATOR REPORTED A POSSIBLE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE AND NO RELATIONSHIP BETWEEN THE EVENT AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR NA V00227353

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention