BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2152041 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04795
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. FACTORS THAT MAY CONTRIBUTE TO A FRACTURED STENT INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED STRUTS, LOW RADIAL FORCE, 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS PART/LOT NUMBER COMBINATION. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. 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 DURING THE THREE YEAR FOLLOW-UP POST XACT STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, A GRADE 1 SINGLE STRUT STENT FRACTURE WAS FOUND IN THE PROXIMAL STENT. THE PATIENT DID NOT REPORT ANY ADVERSE EVENTS PRIOR TO THE STENT FRACTURE OR ANY ADVERSE SEQUELA AFTER THE STENT FRACTURE. NO TREATMENT HAS BEEN PROVIDED. 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 340926G

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR