BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2880563 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08189
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 6, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MODERATELY TORTUOUS AND HEAVILY CALCIFIED RIGHT INTERNAL CAROTID / COMMON CAROTID ARTERY STENTING PROCEDURE, AFTER UNEVENTFUL STENT DEPLOYMENT, THE STENT DELIVERY SYSTEM COULD NOT BE REMOVED. THE PATIENT WAS ASKED TO MOVE THEIR HEAD FROM SIDE TO SIDE AND COUGH, BUT THE SYSTEM REMAINED STUCK. A BUDDY WIRE WAS INSERTED, ENABLING THE DELIVERY SYSTEM TO BE REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE IMPLANTED STENT WAS WELL APPOSED AND THE PROCEDURE DEEMED SUCCESSFUL. 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 2072661

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention