BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 2900007 · Received January 7, 2013

    Report

    Report Number
    2183870-2013-00011
    Event Type
    Death
    Date Received
    January 7, 2013
    Date of Event
    September 25, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF (B)(6).THE CAS PROCEDURE WAS PERFORMED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED WITH A MINOR ISCHEMIC STROKE AND WAS TREATED WITH A CT SCAN, MEDICATION AND AN ECHOCARDIOGRAM. THE SYMPTOMS RESOLVED BY (B)(6) 2012. THEN ON (B)(6) 2012 THE PATIENT EXPIRED. PER THE CLINICAL EVENT COMMITTEE (CEC) THE DEATH WAS CARDIAC RELATED AND NOT RELATED TO THE PROTEGE RX AND SPIDERFX.PLEASE REFERENCE MDR 2183870-2013-00012 FOR THE SPIDERFX USED IN THE CAS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6874 PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-8-6-40-135 9592947

    Patients

    Seq Age Sex Outcome Treatment
    1 91 Death SPIDERFX