BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1153338 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02165
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-02164. A DEVICE HISTORY REPORT REVIEW WAS CONDUCTED AND THIS LOT OF PRODUCTS MET THE REQUIREMENTS PER THE QUALITY MANUFACTURING PLAN. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. TRANSIENT ISCHEMIC ATTACKS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. A TIA IS CAUSED BY THE TEMPORARY DISTURBANCE OF BLOOD SUPPLY TO A RESTRICTED AREA OF THE BRAIN, RESULTING IN BRIEF NEUROLOGIC DYSFUNCTION THAT PERSISTS, BY DEFINITION, FOR LESS THAN 24 HOURS. THERE ARE PT FACTORS SUCH AS THE PTS AGE AND MEDICAL HISTORY AS WELL AS VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE PT WAS A WHITE MALE WEIGHING 113 KGS AND 71 IN TALL. THE PT HAD A HISTORY OF HYPERLIPIDEMIA, DIABETES, CORONARY ARTERY DISEASE, AND HYPERTENSION. AT THE INDEX PROCEDURE, THE TARGET LESION WAS THE LEFT PROXIMAL INTERNAL CAROTID. PRE-PROCEDURE STENOSIS WAS 95%. THE LESION LENGTH WAS 60MM AND DIAMETER WAS 5MM. THE LESION HAD SEVERE CALCIFICATION AND TORTUOSITY. IT WAS ECCENTRIC AND ULCERATED. THE PT WAS SYMPTOMATIC. THE LESION WAS PRE-DILATED. TWO PRECISE STENTS WERE DEPLOYED. A 8 X 40 STENT WAS DEPLOYED AT THE TARGET LESION AND A 10X40 WAS DEPLOYED, OVERLAPPING, PROXIMAL TO THE TARGET LESION. THERE WAS NO STENT MALFUNCTION NOTED. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PT LEFT THE ANGIOGRAPHY SUITE. WHEN THE PT RETURNED TO THE ICU, THE PT EXPERIENCED APHASIA AND RIGHT SIDE HEMIPARESIS, WHICH WAS DIAGNOSED AS A TIA. THE TIA WAS NOT TREATED. THE EVENT LASTED LESS THAN 24 HOURS AND THE PT RETURNED TO HIS NEUROLOGICAL STATUS AT BASELINE (SOME RIGHT SIDE APHASIA). 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 13352849

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening CLOPIDOGREL| ASPIRIN| HEPARIN