BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 2910197 · Received January 11, 2013

    Report

    Report Number
    2183870-2013-00020
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    August 21, 2012
    Report Date
    January 10, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 PERFORMED IN (B)(6). THE PHYSICIAN USED A PROTEGE RX 7 X 30 STENT ALONG WITH EMBOLIC PROTECTION. THE FILTER WAS DEPLOYED AND THE PHYSICIAN THEN ADVANCED THE PROTEGE RX THROUGH A 7F GUIDING CATHETER. BEFORE THE PHYSICIAN COULD DEPLOY THE STENT AT THE SITE OF STENOSIS THE STENT BEGAN TO DEPLOY AND THE STENT WAS PULLED INTO THE ILIAC ARTERY. THE STENT WAS DEPLOYED IN THE ILIAC ARTERY. THE TARGET AREA WAS THE CAROTID, BUT THE PROTEGE RX WAS NOT DEPLOYED THERE. THE PHYSICIAN IMPLANTED A DIFFERENT STENT IN THE CAROTID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16592 PROTÉGÉ ®RX SELF EXPANDING PERIPHERAL STENT SYSTEM STENT, CAROTID NIM EV3 INC. SEPX-7-30-135 9218018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MEDTRONIC CRISTALLO IDEALE STENT| SPIDERFX