BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1905177 · Received November 22, 2010

    Report

    Report Number
    9616695-2010-00048
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. STENT FRACTURE CAN BE A RESULT OF, BUT IS 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. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED STENT FRACTURE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT FOUR YEARS POST SENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY FOLLOW-UP X-RAY REVEALED A GRADE 1 STENT FRACTURE INVOLVING A SINGLE, PROXIMAL STRUT. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-GALWAY 28098-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR