BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION

    MDR report key: 3023994 · Received March 27, 2013

    Report

    Report Number
    2183870-2013-00076
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    June 12, 2012
    Report Date
    February 26, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CREATE PAS: A MAJOR ISCHEMIC STROKE WAS REPORTED. THE PATIENT DEVELOPED AN IPSILATERAL TRANSIENT EPISODE OF LEFT UPPER EXTREMITY NUMBNESS AND APHASIA. THE PATIENT HAD THE LEFT HEMISPHERIC EVENT DURING THE STENT PROCEDURE, THE DURATION OF WHICH WAS GREATER THAN 24 HOURS. PER THE CLINICAL EVENTS COMMITTEE (CEC) THIS EVENT WAS ADJUDICATED AS RELATED TO THE PROCEDURE, BUT PROBABLY NOT TO THE DEVICES. PLEASE REFERENCE MDR 2183870-2013-00075 FOR THE PROTEGE RX USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125930 SPIDERFX EMBOLIC PROTECTION TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-US-050-320 9536220

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other PROTEGE RX