BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1082251 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01843
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PT WAS A MALE. THE PT HAD A HISTORY OF HYPERLIPIDEMIA, HYPERTENSION AND CORONARY ARTERY DISEASE. THE PT HAD AN ABNORMAL STRESS TEST. THE TARGET LESION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION LENGTH 20MM AND VESSEL DIAMETER WAS 7MM. THE LESION WAS 80% STENOSED. THERE WAS MODERATE CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS ECCENTRIC AND ULCERATED. A PRECISE RX 8 X 30MM WAS DEPLOYED AT THE TARGET LESION. RESIDUAL STENOSIS POST-STENT DEPLOYMENT WAS 10%. AN ANGIOGUARD RX, BASKET SIZE 7MM, WAS SUCCESSFULLY DEPLOYED AND RETRIEVED. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. POST STENT IMPLANT AND REMOVAL OF THE ANGIOGUARD, THE PT HAD SUDDEN ONSET DYSARTHRIA AND RIGHT HEMIPARESIS WHICH LASTED 3 MINUTES. THIS WAS DIAGNOSED AS A TIA. THERE WAS NO OBVIOUS SPASM THAT COULD HAVE ACCOUNTED FOR THE EVENT. IT RESOLVED SPONTANEOUSLY WITHOUT TREATMENT ALTHOUGH AN ADDITIONAL 2000 UNITS OF HEPARIN WERE GIVEN AFTER THE ACT REVEALED TO BE 236. AN EMERGENCY CT OF THE BRAIN REVEALED NO ABNORMALITY AND A NEUROLOGICAL EXAM BY BOARD CERTIFIED NEUROLOGIST REVEALED NO DEFECIT. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PT LEFT THE ANGIOGRAPHY SUITE. THE PT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13375114

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening MEDICATIONS: ASPIRIN| CLOPIDOGREL| HEPARIN