BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGE RX SELF EXPANDING NITINOL STENT

    MDR report key: 1702432 · Received May 18, 2010

    Report

    Report Number
    2183870-2010-00085
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    November 5, 2009
    Report Date
    April 26, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. REVIEW OF THIS (B) (6) STUDY EVENT BY THE CLINICAL EVENT COMMITTEE (CEC) BOARD REVIEW FOUND IT TO BE RELATED TO THE INDEX PROCEDURE, BUT NOT THE DEVICES USED.

    Description of Event or Problem · 1

    PT ENROLLED INTO THE (B) (6) TRIAL. THE PT HAD A RIGHT INTERNAL CAROTID ARTERY STENT PLACED ON (B) (6) 2009, AND WAS DISCHARGED FROM THE HOSP ON (B) (6) 2009. THE PT RETURNED ON (B) (6) 2009, WITH HEADACHES AND WAS FOUND TO HAVE AN EXPANDED INTRACEREBRAL HEMORRHAGE WHICH RESULTED IN BRAIN STEM COMPRESSION. THE PT EXPIRED ON (B) (6) 2009. PLEASE REFERENCE MDR 2183870-2010-00086 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-8-6-40-135 7662352

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death