BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 933016 · Received October 25, 2007

    Report

    Report Number
    3004742046-2007-00340
    Event Type
    Injury
    Date Received
    October 25, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 5, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR 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

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PATIENT'S ANATOMY. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCT ANY FINDINGS RELEVANT TO THIS EVENT. THR RX ACCUNET, PART# 1011649-55, LOT# 6071151, REFERENCED IS FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2007-00339.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOM/AE: LEFT OPHTHALMIC ARTERY INFARCTION. TIME OF SYMPTOM/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED A LEFT OPHTHALMIC ARTERY INFARCT RESULTING IN LOSS OF VISION IN THE LEFT EYE. NO TREATMENT WAS GIVEN AND THE VISUAL LOSS IS CONTINUING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6120651

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability HEPARIN| RX ACCUNET