BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2222275 · Received August 24, 2011

    Report

    Report Number
    2024168-2011-05932
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION DURING PROCEDURE WHICH WAS TREATED WITH MEDICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECT AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE RX ACCULINK STENT IMPLANTATION IN THE HEAVILY CALCIFIED LEFT INTERNAL CAROTID ARTERY ON (B)(6) 2011, THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT WAS TREATED WITH MEDICATION, WHICH WAS STOPPED ON (B)(6) 2011. THE MEDICATION WAS RESTARTED ON (B)(6) 2011, REPORTEDLY DUE TO A LARGE EXTRAPERITONEAL HEMATOMA THAT HAD DEVELOPED. MEDICATION WAS AGAIN STOPPED ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED HOME. 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 1033161

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization EMBOLIC PROTECTION: EMBOSHIELD NAV 6