BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2180224 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05254
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 IMAGE OF THE STENT FRACTURE WAS RETURNED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE RESULTS CONFIRM THAT THERE IS A STENT IMPLANTED IN WHAT IS ASSUMED TO BE THE LEFT INTERNAL CAROTID ARTERY. THERE IS A CIRCUMFERENTIAL FRACTURE OF THE STENT STRUTS IN THE PROXIMAL SECTION OF THE STENT. THE STENT IS ALSO COMPRESSED FROM THE PROXIMAL EDGE OF THE STENT TAPERING INTO THE AREA OF FRACTURE. THE CONCLUSION OF THE IMAGE REVIEW CONFIRMS THE CIRCUMFERENTIAL STENT FRACTURE. FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURES INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED STRUTS, LOW RADIAL FORCE, ANATOMICAL CONDITIONS, STRETCHED STENT, FATIGUE, OR INTERACTION WITH OTHER DEVICES. DURING PRODUCTION ALL XACT STENTS ARE 100% VISUALLY INSPECTED FOR STENT DAMAGE (BOTH INTERNALLY AND EXTERNALLY), 100% DIMENSIONALLY MEASURED, AND 100% RADIAL FORCE TESTED. THERE WAS NO DAMAGE NOTED TO THE STENT DURING THE ORIGINAL PROCEDURE. THE REPORTED STENOSIS IN THIS CASE MAY BE THE RESULT OF THE REPORTED FRACTURE; HOWEVER, THIS COULD NOT BE DETERMINED. THE DATE THE STENT WAS ORIGINALLY IMPLANTED WAS NOT AVAILABLE. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. A CONCLUSIVE CAUSE FOR THE STENT FRACTURE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50% IN-STENT RESTENOSIS AND A CIRCUMFERENTIAL STENT FRACTURE WERE FOUND IN AN XACT STENT PREVIOUSLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY. THERE WERE NO REPORTS OF PATIENT INJURY OR ADVERSE EVENTS OCCURRING PRIOR TO THE FINDING. THE PATIENT WAS HOSPITALIZED AND ANOTHER LESION WAS STENTED IN THE CAROTID ARTERY; HOWEVER, NO TREATMENT WAS PROVIDED TO THE RESTENOSED AND FRACTURED STENT. THERE WAS NO ADVERSE SEQUELA REPORTED AND THE PATIENT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other