BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 2881739 · Received December 20, 2012

    Report

    Report Number
    2183870-2012-00245
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    July 30, 2012
    Report Date
    December 7, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4): STENT IMPLANTED (B)(6), 2012.

    Description of Event or Problem · 1

    THIS PROCEDURE IS PART OF (B)(6):A SECOND STENT (UNKNOWN MAKE AND MODEL) NEEDED TO BE PLACED DUE TO A GEOGRAPHIC MISS OF THE PROTEGE RX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-10-7-40-135 9614552

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention