BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1969574 · Received January 24, 2011

    Report

    Report Number
    2024168-2011-00441
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4), LOT # 0081251) THERE WAS NO REPORTED PRODUCT DEFICIENCY. EMBOLISM AND CARDIOVASCULAR ACCIDENT (STROKE) ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE PRODUCT. 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 DURING PRE-DILATATION AND POST-DILATATION IN THE RIGHT INTERNAL CAROTID ARTERY, USING THE VIATRAC BALLOON, THE PATIENT EXPERIENCED BRADYCARDIA THAT RESOLVED WITH A TOTAL OF TWO DOSES OF ATROPINE. AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A STROKE WITH SPEECH DIFFICULTIES THAT WAS CONFIRMED WITH AN MRI OF THE HEAD SHOWING SEVERAL SMALL FOCI OF ACUTE INFARCTION IN THE LEFT CEREBRAL HEMISPHERE AND TWO SMALL FOCI OF ACUTE INFARCTION IN THE RIGHT CEREBRAL HEMISPHERE SUGGESTING AN EMBOLIC EVENT. THE PATIENT'S CONDITION RESOLVED THE FOLLOWING DAY AND WAS DISCHARGED HOME. THERE WAS NO REPORTED INTERVENTION. 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-CT 0040762

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Disability