BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2950456 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00747
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2009
    Report Date
    January 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. THE ACCULINK STENT REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. ESTIMATED DATE OF EVENT. ESTIMATED DATE OF IMPLANT. ESTIMATED THERAPY DATE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF CEREBROVASCULAR ACCIDENT IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XACT 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

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A (B)(6), CONDUCTED BETWEEN (B)(6) 2007 AND (B)(6) 2010, WAS PERFORMED IN (B)(6) PATIENTS IN WHOM CAROTID ARTERY STENTING AND CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED. ALL PATIENTS HAD SIGNIFICANT CAROTID ARTERY STENOSIS (>70%) AND WERE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG). CAROTID ARTERY STENTING WAS TECHNICALLY SUCCESSFUL IN ALL (B)(6) PATIENTS. FOUR PATIENTS WERE COMPLICATED BY HEMORRHAGIC STROKES, ONE OF WHICH DEVELOPED 2-3 HOURS AFTER STENTING AND ONE OCCURRING 4 DAYS AFTER CAS. THE REMAINING TWO STROKES OCCURRED WITHIN 24 HOURS AFTER CAS. TWO CASES OF MYOCARDIAL INFARCTION OCCURRED, 25 DAYS AFTER CAS AND THE OTHER OCCURRED 15 DAYS AFTER CABG. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54930 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability OTHER: EMBOSHIELDSTENT: ACCULINK