BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2400774 · Received January 6, 2012

    Report

    Report Number
    2024168-2012-00066
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. STENT: RX ACCULINK; EMBOLIC PROTECTION: EMBOSHIELD NAV 6. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EVENT AS LISTED IN THE INSTRUCTIONS FOR USE, CAROTID STENT SYSTEM, RX ACCULINK. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS 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 POST IMPLANTATION OF 2 RX ACCULINK STENTS IN THE HEAVILY CALCIFIED LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED HYPOTENSION AND WAS TREATED WITH DOPAMINE. ON (B)(6) 2011, THE PATIENT WAS WEANED FROM THE DOPAMINE AND WAS DISCHARGED HOME. THERE WAS NO ADVERSE SEQUELA AND NO ADDITIONAL INFORMATION 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 1060961

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R