BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1206043 · Received October 21, 2008

    Report

    Report Number
    9616099-2008-02502
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    June 27, 2008
    Report Date
    September 25, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS FEMALE PT WITH A HISTORY OF HYPERLIPIDEMIA, ABNORMAL STRESS TEST, HISTORY OF SMOKING (>5 PACKS OF CIGARETTES), CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION WAS ADMITTED FOR ANGIOGRAPHIC CAROTID EVALUATION. THE PT WAS SYMPTOMATIC FOR CAROTID ARTERY DISEASE AT THE TIME OF EXAM. SHE WAS CONSIDERED HIGH RISK FOR CAROTID INTERVENTION DUE TO CONTRALATERAL CAROTID OCCLUSION, HIGH CERVICAL ICA LESIONS OR CCA LESIONS BELOW THE CLAVICLE, AND AGE 75 YEARS. ANGIOGRAPHY REVEALED A 90%, 15MM STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LIC). THE LESION WAS DESCRIBED AS ULCERATED AND MODERATELY CALCIFIED. THE VESSEL WAS DESCRIBED AS 7.0MM IN DIAMETER AND MODERATELY TORTUOUS. AN ANGIOGUARD DEVICE (7MM BASKET) WAS ADVANCED BEYOND THE TARGET AND WAS DEPLOYED WITHOUT DIFFICULTY. A 9.0X30MM PRECISE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. RESIDUAL STENOSIS WAS 10%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. UPON INSPECTION, DEBRIS WAS NOTED IN THE FILTER. POST PROCEDURE THE PT EXPERIENCED A SUDDEN ONSET OF APHASIA AND RIGHT HEMIPARESIS. THE PT WAS DIAGNOSED WITH TIA. THE SYMPTOMS COMPLETELY RESOLVED WITH NO RESIDUAL DEFICITS WITHIN 24 HOURS. APPROX ONE-MONTH POST INDEX PROCEDURE, THE PT PRESENTED URGENTLY WITH NEUROLOGICAL SYMPTOMS. ANGIOGRAPHY REVEALED OCCLUSION OF THE STENT IN THE PROXIMAL LIC EXTENDING INTO THE OSTIUM OF THE LIC, THE BIFURCATION OF THE LEFT COMMON CAROTID, (LCC) AND THE PROXIMAL LEFT EXTERNAL CAROTID ARTERY (LEC). AN EMERGENT CAROTID ENDARECTOMY WAS PERFORMED. THE PT WAS DISCHARGED FROM THE HOSPITAL AFTER FIVE DAYS WITH A STROKE SCALE SCORE OF 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13243205

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R