BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX SELF EXPANDING NITINOL STENT

    MDR report key: 1833043 · Received August 25, 2010

    Report

    Report Number
    2183870-2010-00144
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT ENROLLED INTO THE (B)(4) TRIAL. PRE-DISCHARGE A MINOR ISCHEMIC STROKE WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELAE. PER SITE THE STOKE WAS RELATED TO THE PROCEDURE BUT NOT THE DEVICE. PLEASE REFERENCE MDR 2183870-2010-00145 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX SELF EXPANDING NITINOL STENT NIM EV3 INC. SECX-10-7-40-135 8111218

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other