BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 766086 · Received September 28, 2006

    Report

    Report Number
    3004742046-2006-00401
    Event Type
    Injury
    Date Received
    September 28, 2006
    Date of Event
    December 19, 2005
    Report Date
    September 5, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK CAROTID STENT SYSTEM, PART # 1011342-30, REFERENCED IS BEING REPORTED UNDER THE SAME MFR REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DECREASED VISUAL ACUITY LEFT EYE, MILD APHASIA, AND SLURRED SPEECH. TIME OF SYMPTOMS/AE: DURING HOSPITALIZATION. IT WAS REPORTED THAT AFTER A CAROTID PROCEDURE OF THE LIC AND LCC, THE PT EXPERIENCED NEUROLOGICAL EVENTS OF DECREASED LEFT EYE VISUAL ACUITY, MILD APHASIA, AND SLURRED SPEECH. THE PT WAS ADMITTED IN 2005 WITH SYMPTOMS OF TRANSIENT ISCHEMIC ATTACK AND CHEST DISCOMFORT. NEUROLOGICAL SYMPTOMS INCLUDED LEFT AND RIGHT HAND NUMBNESS AND OCCASIONAL COMPLAINTS OF VISUAL CHANGES. MI WAS RULED OUT AND THE PT UNDERWENT PTCA OF RIGHT CORONARY ARTERY ON THREE DAYS LATER. ON FOUR DAYS LATER, THE PT UNDERWENT CAROTID STENTING WITH GOOD RESULTS. STATUS POST PROCEDURE, THE PT BEGAN TO EXPERIENCE BLURRINESS IN HER LEFT EYE WITH VISUAL FIELD CUTS, SLURRED SPEECH, AND APHASIA. THE APHASIA AND SLURRED SPEECH WERE RESOLVED ON TWO DAYS LATER. THE PT WAS DISCHARGED TO HOME ON THE SAME DAY. ON NINE DAYS LATER, THE PT WAS SEEN BY AN OPHTHALMOLOGIST WHO STATED THAT THE PT EXPERIENCED AN INFERIOR BRANCH RETINAL ARTERY OCCLUSION. ADD'L VISIT THE FOLLOWING MONTH REVEALED THAT THE VISUAL LOSS WAS "ALMOST COMPLETELY CLEARED." NO ADD'L INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability OTHER: RX ACCUNET| STENT: RX ACCULINK