BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 3037114 · Received April 5, 2013

    Report

    Report Number
    2183870-2013-00087
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    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 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): THE CAS PROCEDURE WAS PERFORMED ON (B)(6) 2013. AT DISCHARGE A MAJOR ISCHEMIC STROKE WAS REPORTED. THE PATIENT WAS FOUND TO HAVE INCREASED RIGHT SIDED WEAKNESS. AN MRI OF THE BRAIN SHOWED A SHOWER OF EMBOLIS ON THE LEFT SIDE. THE PATIENT WAS SENT TO NSU FOR TREATMENT AND MONITORING. THE PATIENT IS NOT YET RECOVERED. PLEASE REFERENCE MDR 2183870-2013-00088 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140414 PROTEGE RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-8-6-40-135 9665550

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SPIDERFX