BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1920300 · Received December 10, 2010

    Report

    Report Number
    3004742046-2010-00598
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 16, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE XACT INSTRUCTIONS FOR USE (IFU), STENT FRACTURE, DEFORMATION AND/OR STENT DAMAGE ARE KNOWN POTENTIAL ADVERSE OUTCOMES ASSOCIATED WITH CAROTID STENTS. NO ANOMALIES TO THE CATHETER WERE REPORTED DURING INSPECTION PRIOR TO USE. IN ADDITION, THERE HAVE BEEN NO STENT RELATED DISCREPANCIES REPORTED AT THE TIME OF DEVICE PREPARATION AND INITIAL STENT IMPLANTATION. AT MANUFACTURING, THE XACT STENT IS 100% VISUALLY INSPECTED UNDER MAGNIFICATION. THE STENTS ARE CHECKED FOR CONCENTRICITY, UNIFORMITY, PATTERN, AND SURFACE FINISH. THE STENTS ARE ALSO CHECKED FOR DEFECTS SUCH AS CRACKS, PITTING AND POOR ELECTRO POLISHING. THE XACT STENT DESIGN IS CAPABLE OF WITHSTANDING EXTREME REPEATED LOADING CONDITIONS WITHOUT EXPERIENCING STRUT CRACKING, BREAKAGES, OR DEFORMATION PER TESTING BASED ON WORST CASE CONDITIONS. THE DEFINITIVE CAUSE OF THE STENT DAMAGE, IF ANY, COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, THE EVENT DOES NOT APPEAR TO BE RELATED TO A PRODUCT DEFICIENCY AND IT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED IF A STENT FRACTURE ACTUALLY OCCURRED. A REVIEW OF THE LOT HISTORY RECORDS (LHR) FOR THIS PRODUCT WERE NOT REVIEWED AS THE LHR RECORDS WERE UNAVAILABLE; HOWEVER, THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE OR ANY PRODUCT DEFICIENCY BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THREE YEARS AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL AND COMMON CAROTID ARTERY, THE PATIENT WAS FOUND TO HAVE A POSSIBLE FRACTURED XACT STENT VIA X-RAY. A THIRD PARTY REVIEWER READ THE X-RAY AS NEGATIVE FOR A STENT FRACTURE. THERE WAS NO REPORTED INTERVENTION AND NO REPORTED PATIENT SYMPTOMS RELATED TO THE STENT FRACTURE. 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 24054-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR EMBOSHIELD NAV6 ((B)(4), LOT 411757)