BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1920265 · Received December 10, 2010

    Report

    Report Number
    3004742046-2010-00596
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 15, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT: 10 X 30 CORDIS PRECISE. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19, LOT 0092851). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION, BRADYCARDIA, HYPOTENSION AND NEUROLOGICAL DEFICIT/ DYSFUNCTION (STROKE OR OTHER NEUROLOGICAL COMPLICATIONS) ARE KNOWN ADVERSE EVENTS 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

    IT WAS REPORTED THAT AFTER THE DEPLOYMENT OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A DISSECTION REQUIRING TREATMENT WITH A NON-ABBOTT STENT TO COVER THE DISSECTION IN THE RIGHT COMMON CAROTID ARTERY. DURING THE PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND A BRIEF EPISODE OF BRADYCARDIA THAT WAS TREATED WITH NEOSYNEPHRINE AND ONE DOSE OF ATROPINE. THE PATIENT ALSO EXPERIENCED RIGHT SIDED EYE DEVIATION AND LEFT SIDED WEAKNESS THAT WAS DIAGNOSED AS HYPOPERFUSION. THE PATIENT'S HYPOTENSION AND RIGHT SIDED EYE DEVIATION RESOLVED SEVEN DAYS AFTER THE PROCEDURE, BUT THE PATIENT CONTINUES TO HAVE LEFT SIDED WEAKNESS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE.SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-VS 9050851

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R| S