BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3061990 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02334
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT 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 AN ACCULINK STENT WAS IMPLANTED IN A DE NOVO, 90% STENOSED, NONE-MILDLY CALCIFIED, LEFT INTERNAL CAROTID ARTERY, AND POST-PROCEDURE, THE NEXT DAY, THE PATIENT EXPERIENCED HYPOTENSION WITH THE BLOOD PRESSURES IN THE 70-80'S RANGE. THE PATIENT'S HYPERTENSIVE MEDICATION, METOPROLOL, WAS HELD AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE PATIENT'S BLOOD PRESSURE RETURNED TO NORMAL ON (B)(6) 2013 AT A CLINIC VISIT. ON (B)(6) 2013, AT A 30 DAY FOLLOW-UP VISIT, THE PATIENT WAS HYPERTENSIVE WITH BLOOD PRESSURES OF 162/84 (LEFT SIDE) AND 158/80 (RIGHT SIDE). THE PATIENT WAS RE-STARTED ON THE ROUTINE HYPERTENSIVE MEDICATION, METOPROLOL ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162531 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2092561

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other