BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3171241 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03760
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    September 25, 2012
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 EFFECT OF HEADACHE IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST RX ACCULINK STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A HEADACHE AND BLURRED VISION THAT WERE TREATED WITH TYLENOL AND ULTRAM. ON (B)(6) 2012, THE HEADACHE RESOLVED AND THE PATIENT WAS DISCHARGED HOME. LATER IN THE DAY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM STILL REPORTING THE BLURRED VISION AND WAS RE-ADMITTED TO THE HOSPITAL. ON (B)(6) 2012, THE BLURRED VISION RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271829 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2050761

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization EMBOLIC PROTECTION: RX ACCUNET