BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1962139 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00346
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST XACT STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT IN THE RIGHT MIDLINE PONTINE WITH DIPLOPIA. TREATMENT INCLUDED CONTINUATION OF ASPIRIN, CLOPIDOGREL AND PROLONGED HOSPITALIZATION. THE PATIENT'S CONDITION IS CONTINUING BUT IMPROVED. THE PATIENT WAS DISCHARGED HOME FIVE DAYS POST PROCEDURE. THOUGH REQUESTED, 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 0101961

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| S EMBOSHIELD NAV6HEPARINASPIRINCLOPIDOGREL