BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION

    MDR report key: 3122008 · Received May 21, 2013

    Report

    Report Number
    2183870-2013-00121
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    August 25, 2012
    Report Date
    April 29, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 (B)(6): A TIA WAS REPORTED 2 WEEKS AFTER THE CAS PROCEDURE. THE CAS PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE PATIENT RETURNED TO THE ER COMPLAINING OF RIGHT SIDED WEAKNESS FOR 48 HOURS. IT WAS DETERMINED BY THE PI THAT THERE WAS NO SIGNIFICANT CHANGE FROM THE WEAKNESS OF BASELINE. THE PATIENT WAS GIVEN MEDICATION AND HAS NOT YET RECOVERED. PLEASE REFERENCE MDR 2183870-2013-00122, FOR THE PROTEGE RX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223707 SPIDERFX EMBOLIC PROTECTION TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-US-050-320 9617294

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other