BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2072268 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02985
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    February 19, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF BRADYCARDIA IS LISTED IN THE XACT INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY. ONE DAY POST PROCEDURE, THE PATIENT DEVELOPED ASYMPTOMATIC BRADYCARDIA. NO TREATMENT WAS GIVEN. THERE WAS NO CHANGE IN NEUROLOGIC STATUS. ADDITIONALLY, ONE DAY POST PROCEDURE, AFTER ARTERIOTOMY CLOSURE USING A NON-ABBOTT DEVICE, A SMALL RIGHT GROIN HEMATOMA DEVELOPED. MANUAL PRESSURE WAS HELD AND A PRESSURE DRESSING WAS APPLIED TO THE HEMATOMA. THE HEMATOMA WAS REPORTED AS UNCHANGED AND THE PATIENT WAS DISCHARGED TO HOME ONE DAY POST PROCEDURE. THE BRADYCARDIA RESOLVED ON 03/24/2011. 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-TEMECULA-CT 0052461

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other