BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2133957 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04349
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. AN ABNORMAL X-RAY SHOWING STENT FRACTURE CAN BE A RESULT OF, BUT NOT LIMITED TO, STENT MATERIAL, POST DILATATION TECHNIQUE, ANATOMICAL MOTION RESULTING IN STRESS/FATIGUE OF THE STENT MATERIAL AND/OR INTERACTION WITH OTHER DEVICE POST DEPLOYMENT. SINCE THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, THIS SUGGESTS THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED STENT FRACTURE COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS INITIATED AGAINST THIS FINISHED GOOD LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOUND NO SIMILAR INCIDENTS OF STENT FRACTURE REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. ALL STENTS ARE SUBJECTED TO A 100% VISUAL INSPECTION FOR DAMAGE AND BREAKS. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE A PROXIMAL, GRADE 4, TRANSVERSE STENT FRACTURE APPROXIMATELY THREE YEARS AFTER THE IMPLANTATION OF THE XACT STENT IN THE CALCIFIED RIGHT INTERNAL CAROTID ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO REPORTED INTERVENTION. 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 350106G

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR