BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 2900048 · Received January 7, 2013

    Report

    Report Number
    2183870-2013-00013
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    March 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF CREATE PAS: THE CAS PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE PATIENT WAS REHOSPITALIZED ON (B)(6) 2012 DUE TO A MINOR HEMORRHAGIC STROKE. IT WAS REPORTED AS A SMALL BASAL GANGLIA HEMORRHAGE. THE SYMPTOMS ENDED BY MARCH 10, 2012 AND THE PATIENT RECOVERED WITHOUT SEQUELAE. PLEASE REFERENCE MDR 2183870-2013-00014 FOR THE SPIDERFX USED IN THE CAS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6980 PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-10-7-40-135 9512181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SPIDERFX