BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1981997 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00768
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    September 28, 2010
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CEREBROVASCULAR ACCIDENT IS A KNOWN ADVERSE EVENT LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22437-19, LOT # 0083051). THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED NEUROLOGICAL DEFICIT IS A KNOWN ADVERSE EVENT AS LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS EVENT WAS DETERMINED TO BE A MINOR ISCHEMIC IPSILATERAL STROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A HEADACHE AND LEFT SIDE WEAKNESS. THE PATIENT WAS TREATED WITH OBSERVATION AND PHYSICAL THERAPY. THE PATIENT'S CONDITION HAD RESOLVED WITH SOME SEQUELA BY THE 30 DAY FOLLOW UP VISIT. 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 529695

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O