BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1945102 · Received January 3, 2011

    Report

    Report Number
    3004742046-2011-00004
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMBOLIC PROTECTION: EMBOSHIELD NAV6 (22438-19/0101251). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RLEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. HYPOTENSION AND BRADYCARDIA ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 VIA A TRIAL THAT AFTER THE IMPLANTATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA THAT REQUIRED TREATMENT WITH NEOSYNEPHRINE, DOPAMINE, FLUID BOLUS, AND ONE DOSE OF ATROPINE. THE HYPOTENSION RESOLVED TWO DAYS POST PROCEDURE UPON DISCHARGE. THERE WAS NO ADVERSE PATIENT SEQUELA. 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-VS 0080961

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R