BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1061011 · Received June 12, 2008

    Report

    Report Number
    9616099-2008-01504
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CAROTID STENTING PROCEDURE, THE PRECISE STENT WAS REPORTED TO HAVE JUMPED FORWARD DURING DEPLOYMENT, AND WAS THEREFORE NOT PLACED IN THE INTENDED POSITION. IT WAS IMPLANTED DISTAL TO THE TARGET LESION, SO THE PHYSICIAN DEPLOYED ANOTHER UNK STENT TO COMPLETELY COVER THE LESION. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS PER THE REPORTING AFFILIATE, TARGET LESION CHARACTERISTICS AND PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF 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 13357815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 6MM ANGIOGUARD