BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 3670985 · Received March 10, 2014

    Report

    Report Number
    2024168-2014-01400
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: EMBOLIC PROTECTION: EMBOSHIELD NAV6 22438-19, LOT 3062662. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY ADVANCING AND RESISTANCE DURING REMOVAL COULD NOT BE REPLICATED AS IT WAS BASED ON CASE CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO SIMILAR INCIDENTS OF RESISTANCE ON ADVANCEMENT OR REMOVAL REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XACT STENT DELIVERY SYSTEM (SDS) ENCOUNTERED A LOT OF RESISTANCE WHEN ADVANCING OVER THE EMBOSHIELD NAV 6 BAREWIRE. THE XACT SDS REACHED THE TYPE 3 AORTIC ARCH, BUT WOULD NOT CROSS THE MODERATELY TORTUOUS COMMON CAROTID ARTERY. SOME RESISTANCE WAS ALSO ENCOUNTERED WHEN REMOVING THE XACT SDS FROM THE BAREWIRE. AN ACCULINK OF THE SAME SIZE TRACKED OVER THE SAME BAREWIRE AND REACHED THE HEAVILY CALCIFIED TARGET LESION IN THE RIGHT INTERNAL CAROTID ARTERY WITHOUT FURTHER INCIDENT. THERE WAS NO KINK VISUALIZED ON THE XACT SDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143258 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 3071961

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR