BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1002206 · Received February 21, 2008

    Report

    Report Number
    9616099-2008-00422
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 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

    THE 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 PRODUCTS THAT WAS USED IN THE PROCEDURE AND IS RELATED TO MFG # 1016427-2008-00041 AND 9616099-2008-00422.

    Description of Event or Problem · 1

    DURING A CAROTID STENTING PROCEDURE, BLOOD FLOW WAS INCREASED. PARALYSIS AND CONSCIOUSNESS DISORDER OCCURRED. THERE WAS NO INFRACTION / BLEEDING FOUND ON CAT SCAN AND MR. THE PATIENT WAS TREATED BY SIMMER DOWN AND ANTIHYPERTENSIVE AND FULLY RECOVERED. PATIENT IS A MALE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS IN STABLE CONDITION. PLEASE NOTE THAT ADDITIONAL PATIENT AND PROCEDURAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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 13287406

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R