BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX¿ EMBOLIC PROTECTION DEVICE

    MDR report key: 2881731 · Received December 20, 2012

    Report

    Report Number
    2183870-2012-00250
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 14, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 IS PART OF (B)(6):A MAJOR ISCHEMIC STROKE WAS REPORTED. THE SAME DAY OF THE LICA STENTING ON (B)(6), 2012, THE SUBJECT WAS NOTED TO HAVE DECREASED MOVEMENT ON THE RIGHT SIDE. AN MRI WAS SUGGESSTIVE OF A "WATERSHED ISCHEMIC STROKE" PROBABLY DUE TO THE POST PROCEDURE HYPOTENSION. PATIENT IS NOT YET RECOVERED.PLEASE REFERENCE MDR 2183870-2012-00249 FOR THE PROTEGE RX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX¿ EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-US-070-320 9630461

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other PROTEGE RX