BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1051644 · Received May 21, 2008

    Report

    Report Number
    9616099-2008-01367
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 12, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    FOUR DAYS AFTER BEING DISCHARGED THE PATIENT SUFFERED A STROKE. THE PATIENT IS A MALE WITH KNOWN CEREBROVASCULAR DISEASE AND RECENT CVA. HE WAS ADMITTED TO THE HOSPITAL IN 2008 FOR NEW RIGHT BRAIN STROKE SYMPTOMS WITH DOCUMENTATION OF A WATERSHED DISTRIBUTION STROKES ON MRI. THE PATIENT HAD A PRECISE STENT PLACED IN THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY ON THE FOLLOWING MONTH. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON TWO DAYS LATER. THE PATIENT WAS IN HIS USUAL STATE OF HEALTH UNTIL FOUR DAYS LATER, WHEN HE FELL AT HOME. ACCORDING TO THE PATIENT'S WIFE, SHE HAD CALLED HOME AFTER HE FELL. HE WAS ABLE TO CRAWL TO THE PHONE AND TELL HER THAT HE HAD FALLEN. SHE NOTICED WHEN SPEAKING TO HIM THAT HIS SPEECH WAS SLURRED AND THEREFORE CALLED EMS. THE PATIENT WAS ADMITTED THAT DAY. ON TWO DAYS LATER, AN MRI REVEALED A NEW FRONTAL RIGHT FRONTAL AND NEW RIGHT PARIETAL ISCHEMIC AREA, WHICH WAS VERY SMALL. THE PATIENT WAS PLACED ON ASPIRIN, PLAVIX, TRICOR, AND ZOCOR. THE PATIENT'S CONDITION GRADUALLY IMPROVED. HIS GAIT BECAME STABILIZED AND HIS SPEECH BECAME CLEAR AND NORMAL. THE PATIENT WAS DISCHARGED HOME ON FOUR DAYS LATER.

    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 13328823

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R ANGIOGUARD