BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1914549 · Received December 3, 2010

    Report

    Report Number
    3004742046-2010-00576
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-TEMECULA
    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). STENT: 8-6X30 XACT (CATALOGUE 82091-01, LOT 9111151) - (B)(6) 2010. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (CATALOGUE 22438-19, LOT # 0092951) - (B)(6) 2010. THE RESTENOSED XACT STENT WILL BE FILED UNDER A SEPARATE MFR NUMBER. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. A NEUROLOGICAL EVENT, EMBOLISM, AND HEMORRHAGE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE PATIENT WAS FOUND TO HAVE IN-STENT RESTENOSIS OF THE 8-6X30 XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, APPROXIMATELY 8 MONTHS AFTER IMPLANTATION. DURING TREATMENT OF THAT RESTENOSIS WITH THE 8X20 XACT STENT, THE PATIENT EXPERIENCED A SLIGHT WEAKNESS IN THE LEFT HAND, BUT QUICKLY RETURNED TO HER BASELINE WITHIN FIVE MINUTES. SEVERAL HOURS AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE LEFT FACIAL DROOP. THE CT SCAN SHOWED A SUBARACHNOID HEMORRHAGE IN THE RIGHT HEMISPHERE. THE MRI ALSO SHOWED ACUTE AND SUBACUTE MICROEMBOLIC SHOWERS. THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY IN STABLE CONDITION, BUT HAD RESIDUAL LEFT SIDED WEAKNESS. 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 0011951

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S