BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2211839 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05732
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    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. VIATRAC DILATATION CATHETER, EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE, HEPARIN. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF BRADYCARDIA AND HYPOTENSION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 THAT AN XACT STENT WAS DEPLOYED IN THE HEAVILY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. FOLLOWING POST-DILATATION, USING A VIATRAC BALLOON, ASYMPTOMATIC HYPOTENSION AND BRADYCARDIA OCCURRED, TREATED WITH ATROPINE AND INTRAVENOUS FLUID BOLUS. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY. HYPOTENSION AND BRADYCARDIA HAD IMPROVED BUT WAS CONTINUING. BASELINE ANTIHYPERTENSIVE MEDICATIONS WERE HELD DURING HOSPITALIZATION AND AT THE TIME OF DISCHARGE; THE PATIENT WAS INSTRUCTED TO RESUME BETA-BLOCKER MEDICATION IN ONE WEEK AND HOLD ACE INHIBITOR UNTIL SEEN FOR 30 DAY FOLLOW-UP. 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 1042161

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention