BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2182629 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05354
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    April 17, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF STROKE, HEMORRHAGE AND HYPERTENSION ARE KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED ADVERSE PATIENT EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 DAYS POST RX ACCULINK STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SLIGHT CONFUSION AND APRAXIA, WHICH WAS DIAGNOSED AS A STROKE. CT SCAN SHOWED AN ACUTE FRONTAL HEMATOMA. THE PATIENT WAS HOSPITALIZED AND TREATED FOR HYPERTENSION. THE EVENT RESOLVED ON (B)(6) 2011 AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0032661

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R| S