BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 2781208 · Received October 10, 2012

    Report

    Report Number
    2183870-2012-00198
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 17, 2012
    Report Date
    September 12, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. STENT IMPLANTED ON (B)(6) 2012

    Description of Event or Problem · 1

    THE CAS PROCEDURE WAS PART OF (B)(6): THE PROCEDURE DATE WAS (B)(6), 2012. DURING THE PROCEDURE THE PATIENT EXPERIENCED A TIA THEN MINOR ISCHEMIC STROKE. THEN ON (B)(6), 2012 THE PATIENT EXPERIENCED AN MYOCARDIAL INFARCTION, FOLLOWED ON (B)(6), 2012 BY A TONIC CLONIC SEIZURE. THE PATIENT IS NOT YET RECOVERED FROM THE STROKE. PLEASE REFERENCE MDR 2183870-2012-00199 FOR THE SPIDERFX USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-8-6-40-135 9609617

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other SPIDERFX