BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2964406 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00924
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HYPOTENSION, NEUROLOGICAL DEFICIT DYSFUNCTION, AND PAIN ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS 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 DURING A HEAVILY CALCIFIED LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION WHICH WAS TREATED WITH DOPAMINE AND ATROPINE AND RESOLVED ON THE SAME DAY. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED A WORSENING OF LEG NUMBNESS AND PAIN. THE PAIN IS BEING TREATED WITH ACETAMINOPHEN HYDROCODONE. THE CONDITION IS NOTED AS CHRONIC WITH SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68331 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2090461

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability EMBOLIC PROTECTION: RX ACCUNET