BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1032359 · Received April 22, 2008

    Report

    Report Number
    9616695-2008-00051
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 31, 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

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE RX ACCULINK PART# 1011337-20, LOT# 7020751 IS BEING FILED UNDER MEDWATCH REPORT NUMBER 3004742046-2008-00087.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: LEFT RETINAL EMBOLUS. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT ONE DAY POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, THE PATIENT EXPERIENCED LEFT EYE PARTIAL LOSS OF VISION. REPORTEDLY, 2 LESIONS IN THE LEFT INTERNAL CAROTID ARTERY WERE STENTED USING AN RX ACCULINK AND AN XACT STENT DEVICE. A HEAD CT WAS PERFORMED WHICH WAS NEGATIVE. A NEUROLOGIST WAS CONSULTED AND FINDINGS WERE LEFT RETINAL ARTERY EMBOLUS. NIHSS BY NEUROLOGIST WAS 0, CRANIAL NERVES II - XII INTACT. THERE WAS NO TREATMENT REPORTED AND THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY; THE CONDITION IS REPORTED AS CONTINUING, UNCHANGED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. CHOICE STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 370996G

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability RX ACCULINK PART# 1011337-20| BIVALIRUDIN| LOT# 7020751