BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2863671 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07808
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. RESTENOSIS, IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT OF STENTING PROCEDURES AS LISTED IN THE XACT CAROTID STENT SYSTEM INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE 9S X 30 X 136 XACT STENT WAS IMPLANTED IN THE CAROTID ARTERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(4) 2012, AN ULTRASOUND WAS PERFORMED WHICH FOUND THAT THE XACT STENT WAS 80% BLOCKED AND THE RIGHT SIDE OF THE STENT WAS BENT AT A 45 DEGREE ANGLE. NO TREATMENT HAS BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0011351

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization