BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 1887968 · Received October 27, 2010

    Report

    Report Number
    2953200-2010-02063
    Event Type
    Death
    Date Received
    October 27, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 27, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ONE COMPLETE SE SFA PERIPHERAL STENT, 7X60X130MM, WAS IMPLANTED TO RIGHT DISTAL SFA DURING INDEX PROCEDURE. THERE WAS NO OCCURRENCE OF DEVICE MALFUNCTION. PATIENT DIED APPROXIMATELY 5 MONTHS POST PROCEDURE. INVESTIGATOR DID NOT ASSESS IF DEATH WAS RELATED TO THE DEVICE OR THE PROCEDURE. COMPLETE SE SFA IS A PRE-MARKET STUDY DEVICE BUT IS SIMILAR TO COMPLETE SE ILIAC/BILIARY WHICH IS APPROVED IN THE US AND COMPLETE SE ILIAC WHICH IS APPROVED OUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR NA V00173445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death