BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2072703 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-02992
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    April 5, 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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF TRANSIENT ISCHEMIC ATTACK IS A KNOWN ADVERSE EVENT LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A STUDY THAT TWO DAYS POST RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE THE PATIENT HAD LEFT SIDE FACIAL DROOPING, DROOPING OF THE EYE AND SLURRED SPEECH. THIS LASTED 30-35 MINUTES AND WHEN THE PATIENT PRESENTED TO THE HOSPITAL ALL SYMPTOMS HAD RESOLVED. ASPIRIN WAS GIVEN. A COMPUTED TOMOGRAPHY (CT) OF THE HEAD SHOWED NO ACUTE INTRACALVARIAL HEMORRHAGE OR INFARCT. THIS WAS DIAGNOSED AS A TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND OBSERVATION. 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 0102661

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R