BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1003548 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00441
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THS PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO CORDIS PRODUCTS THAT WAS INVOLVED IN THE SAME PROCEDURE AND IS RELATED TO MFG# 9616099-2008-00441 AND 1016427-2008-00043.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A BRAIN INFARCTION WHEN DISTAL EMBOLIZATION OCCURRED DURING A CAROTID STENTING PROCEDURE. THE PATIENT IS A MALE. THE TARGET LESION WAS THE CAROTID ARTERY (SIDE UNKNOWN). THERE IS NO INFORMATION REGARDING THE TARGET LESION CHARACTERISTICS. THE DIAMETER OF THE VESSEL IS UNKNOWN. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS IN PLACE IN THE VESSEL, AND A PRECISE STENT HAS BEEN SUCCESSFULLY DEPLOYED IN THE LESION WHEN THE EVENT OCCURRED. ARGATROBAN, CLOPIDOGREL, AND ASPIRIN WERE GIVEN INTRA PROCEDURE AND AFTER THE EVENT OCCURRED. IT WAS NOTED THAT ON THE SAME DAY OF THE PROCEDURE, THE PATIENT HAD A SEIZURE, AND INTUBATION WAS NEEDED. THE PATIENT IS RECOVERING, BUT MILD PARALYSIS ON RIGHT LIMB REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13285619

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R