BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 809091 · Received January 22, 2007

    Report

    Report Number
    3004742046-2007-00030
    Event Type
    Injury
    Date Received
    January 22, 2007
    Date of Event
    September 26, 2006
    Report Date
    January 4, 2007
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    p040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: RIGHT EYE BLURRINESS WITH DECREASED PERIPHERAL VISION. TIME OF SYMPTOMS/AE: AFTER THE CAROTID STENTING PROCEDURE IN 2006. IT WAS REPORTED THAT THE PT EXPERIENCED RIGHT EYE BLURRINESS WITH DECREASED PERIPHERAL VISION AFTER RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE. THE PT WAS DISCHARGED THE NEXT DAY, 1 DAY POST PROCEDURE AND THE EVENT WAS CONTINUING. THE EVENT WAS REPORTED TO BE RESOLVED ON 10/26/2006, 30 DAY FOLLOW UP VISIT. NO ADD'L INFO WAS AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6061351

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability OTHER: RX ACCUNET