BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1111887 · Received August 12, 2008

    Report

    Report Number
    9616695-2008-00122
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    March 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS, AND NO DEVICE MALFUNCTION WAS REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY EXCEPTIONS RELATED TO THIS EVENT. NON-STROKE NEUROLOGICAL EVENTS AND EMBOLISM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF CAROTID STENTS AS STATED IN THE DEVICE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: LEFT EYE RETINAL ARTERY OCCLUSION. TIME OF SYMPTOMS/AE: APPROXIMATELY 26 DAYS POST PROCEDURE. IT WAS REPORTED THAT IN 2008, APPROXIMATELY 26 DAYS POST A LEFT INTERNAL/COMMON CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED A BLURRY SPOT IN THE PERIPHERAL VISION. THE PATIENT WAS EVALUATED BY A RETINA AND VITREOUS SURGEON ON FOUR MONTHS LATER, AND WAS DIAGNOSED WITH A LEFT EYE RETINAL ARTERY OCCLUSION AND A CHOLESTEROL PLAQUE. THERE WAS NO REPORTED TREATMENT AND THE PATIENT WILL BE OBSERVED CLOSELY FOR ANY CHANGES. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 393658

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability