BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1961840 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00318
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. DIL CATH: VIATRAC. OTHER: HEPARIN, ASPIRIN, PLAVIX. EMBOLIC PROTECTION: EMBOSHIELD NAV6 (B)(4). STROKE AND RESPIRATORY DISTRESS MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, AND STROKE, EMBOLISM AND RESPIRATORY ARREST ARE KNOWN POTENTIAL ADVERSE EVENTS 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 EFFECTS 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 THAT DURING THE XACT STENT IMPLANTATION, AFTER POST-DILATATION IN THE RIGHT CAROTID ARTERY, THE PATIENT BECAME LESS RESPONSIVE AND WAS INTUBATED. MRI RESULTS, THREE DAYS POST PROCEDURE, INDICATED A NEW CEREBROVASCULAR ACCIDENT. THE PATIENT'S CONDITION IS IMPROVED BUT CONTINUES TO HAVE LEFT-SIDED WEAKNESS. THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER THE PROCEDURE. ALTHOUGH REQUEST, 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 0042261

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R| S