BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 897088 · Received August 14, 2007

    Report

    Report Number
    9616099-2007-01581
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    July 28, 2007
    Report Date
    August 1, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT AVAILABLE FOR ANALYSIS AS STATED. ADDITIONAL INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED IN THE STUDY WITH A PRECISE STENT IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY. AS PART OF THE STUDY PROTOCOL, CARDIAC ENZYMES LABS WERE DRAWN DAY 1 OF THE POST-CAROTID STENTING PROCEDURE AND INCIDENTALLY DETECTED AN ACUTE CORONARY SYNDROME/NON-Q-WAVE MYOCARDIAL INFARCTION, SILENT IN NATURE. UPON EVALUATION, THE PT COMPLAINED OF DIZZINESS WHEN SITTING UP. THE PT'S CARDIAC ENZYME RESULTS WHERE ABNORMAL WITH A TROPONIN OF 12.5 AND A CK OF 450 WITH A POSITIVE MB. AN EKG WAS COMPLETED WHICH DID SHOW SINUS RHYTHM WITH VOLTAGE CRITERIA FOR LVH AS WELL AS LATERAL ST DEPRESSION. THERE WAS NO PREOP BASELINE EKG TO COMPARE. THE PT DENIES CHEST PAIN, SHORTNESS OF BREATH, ORTHOPNEA, OR PND. THE PT HAS NOT HAD SYNCOPE. PATIENT HAS NEVER EXPERIENCED CHEST PAIN AND HAS NEVER UNDERGONE FORMAL ISCHEMIC EVAL AND IS NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA 13160762

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR