BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1101792 · Received August 5, 2008

    Report

    Report Number
    9616099-2008-01920
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE STENT IS IMPLANTED, THE PRODUCT IS NOT AVAILABLE FOR EVAL. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    STENT INCORRECT LENGTH. THE REPORT RECEIVED INDICATED THAT DURING A CAROTID ARTERY STENTING, THE PHYSICIAN COULD NOT PLACE THE PRECISE OTW NITINOL STENT AT THE TARGET LESION PROPERLY AS THE STENT LENGTH WAS SHORT FOR THE LESION AND COULD NOT COVER THE ENTIRE LESION. IT WAS INDICATED THAT THE PHYSICIAN MISJUDGED THE LESION ON IMAGING. AS A RESULT, ANOTHER STENT WAS ADDED TO COVER THE LESION AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PT. THERE WERE NO PROBLEMS ENCOUNTERED ADVANCING OR WHILE DEPLOYING THE STENT. THE ONLY PROBLEM ENCOUNTERED WAS THAT THE STENT COULDN'T COVER THE TARGET LESION WITH ONE STENT. THE TARGET LESION WAS THE CAROTID ARTERY AND DID NOT PRESENT CALCIFICATION OR VESSEL TORTUOSITY; THE RATE OF STENOSIS UNK. PRIOR TO USE, THE PRODUCT PACKAGING WAS SEALED AS INTENDED AND THERE WAS NOTHING UNUSUAL NOTED ON THE STENT DELIVERY SYSTEM. THE DEVICE WAS INSPECTED AND PREPPED AS PER THE INSTRUCTIONS FOR USE.

    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 13166585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention