BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2103249 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03699
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND MYOCARDIAL INFARCTION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE PRODUCT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST UNEVENTFUL XACT STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, THE PATIENT EXPERIENCED CHEST PAIN, ANXIETY, SHORTNESS OF BREATH AND DIAPHORESIS. EKG SHOWED ST ELEVATION AND THE PATIENT WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS IMMEDIATELY TAKEN BACK TO THE CATHETERIZATION LAB AND STENTED WITH A 3.5 X 23 XIENCE V STENT IN THE PROXIMAL CIRCUMFLEX ARTERY FOR A 95% STENOSIS. THE PATIENT RECOVERED AND WAS DISCHARGED HOME ONE DAY AFTER THE PROCEDURE. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0020951

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S