BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1971075 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00468
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    April 22, 2010
    Report Date
    January 3, 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. DILATATION CATHETER: VIATRAC 14 PLUS (PART#1008195-20, LOT 9101551), EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (PART#22438-19, LOT # 0031651), HEPARIN. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE XACT INSTRUCTIONS FOR USE, HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. HYPOTENSION MAY OCCUR DURING CAROTID INTERVENTIONAL PROCEDURES AND IT IS ANTICIPATED RESPONSE OF THE HUMAN BODY TO STIMULUS OF THE CAROTID BULB. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT 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 POST DILATATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY USING A VIATRAC BALLOON AT 6 ATMOSPHERES FOR 16 SECONDS, THE PATIENT EXPERIENCED HYPOTENSION THAT WAS TREATED WITH A FLUID BOLUS. THE PATIENT'S ANTI-HYPERTENSIVE MEDICATIONS WERE HELD AND THE PATIENT WAS STARTED ON ORAL MIDODRINE THE DAY AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME THE DAY AFTER THE PROCEDURE. THE PATIENT'S CONDITION FULLY RESOLVED 13 DAYS AFTER THE PROCEDURE WHEN THE MIDODRINE WAS DISCONTINUED. 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-CT 0011151

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention