BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2863208 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07758
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ADD'L DEVICES: OTHER: ASPIRIN, BIVALIRUDIN; EMBOLIC PROTECTION: EMBOSHIELD NAV6. 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 THE PATIENT UNDERWENT A STENTING PROCEDURE ON (B)(6) 2012 WITH PLACEMENT OF A 7-10 X 40 MM ACCULINK STENT IN THE MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. POST PROCEDURE, THE PATIENT EXPERIENCED AN EPISODE OF HYPOTENSION. DOPAMINE AND MIDODRINE WERE ADMINISTERED; HOWEVER, THE HYPOTENSION CONTINUES. THE PATIENT WAS DISCHARGED TO HOME WITH ORDERS FOR MIDRODRINE. 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 2011861

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention