BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM

    MDR report key: 2872612 · Received December 13, 2012

    Report

    Report Number
    2183870-2012-00237
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 27, 2012
    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): MINOR ISCHEMIC STROKE REPORTED. SHORTLY AFTER POST-DILATATION OF THE PROTEGE RX STENT, THE PATIENT BECAME DYSARTHRIC, SOMEWHAT SOMNOLENT, BUT FOLLOWED COMMANDS & MOVED ALL 4 EXTREMITIES. THE PATIENT THEN PROGRESSED TO BEING UNABLE TO MOVE THEIR RIGHT FOOT TO COMMAND RIGHT HAND GRASP LESS THAN THE LEFT. THE PATIENT RECOVERED WITH SEQUELAE. PLEASE REFERENCE MDR 2183870-2012-00236 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM STENT, CAROTID NIM EV3 INC. SECX-8-6-40-135 9443702

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other SPIDERFX