BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 771262 · Received October 17, 2006

    Report

    Report Number
    3004742046-2006-00431
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    September 22, 2006
    Report Date
    September 25, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND RX ACCULINK, PART# 1011344-40, LOT # 6082251, IS INDICATED IN THE EVENT DESCRIPTION AND IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOM/AE: VISION LOSS RIGHT EYE. TIME OF SYMPTOM/AE: POST PROCEDURE. IT WAS REPORTED THAT THE SAME DAY POST RICA STENTING, THE PATIENT DEVELOPED TOTAL VISUAL LOSS OF THE RIGHT EYE. THE PATIENT HAD A HISTORY OF PREVIOUS STROKES, GLAUCOMA AND BILATERAL CATARACTS WITH POOR VISION BILATERALLY. THE TARGET LESION WAS 80% STENOSED AND HEAVILY CALCIFIED. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT DEVELOPED TOTAL VISUAL LOSS TO THE RIGHT EYE AND HALLUCINATIONS. THE HALLUCINATIONS RESOLVED THE SAME DAY, BUT VISUAL LOSS PERSISTS. NEUROLOGICAL AND OPHTHALMOLOGY CONSULTATIONS WERE INCONCLUSIVE FOR ETIOLOGY OF VISION LOSS. CT SCAN OF HEAD WAS REPORTEDLY INCONCLUSIVE. HOSPITALIZATION WAS PROLONGED AND THE PT WAS DISCHARGED TO REHABILITATION WITHOUT CONCLUSIVE ETIOLOGY OF RIGHT EYE VISION LOSS. ADDITIONALLY POST PROCEDURALLY, THE PATIENT DEVELOPED A NON-REACTIVE LEFT PUPIL THAT RESOLVED WITHIN A FEW HOURS AND WAS FELT TO HAVE BEEN DUE TO ATROPINE AND GLAUCOMA. ADDITIONAL INFORMATION IS UNAVAILABLE.

    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 6061351

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| S RX ACCUNET| RX ACCULINK