BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2220892 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05916
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EMBOLIC PROTECTION: INVATEC - (B)(4) ULTRA-PROXIMAL CEREBRAL PROTECTION DEVICE 9F. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF HEMORRHAGE AND NEUROLOGICAL EVENT ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE PATIENT EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST XACT STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY (LICA), THE PATIENT DEVELOPED RIGHT FACIAL DROOP, RIGHT SIDED WEAKNESS AND SLURRING OF WORDS. PER CT SCAN, THERE WAS A HEMORRHAGE IN THE LEFT BASAL GANGLIA. THE EVENT WAS DIAGNOSED AS HYPERPERFUSION SYNDROME. THE PATIENT CONTINUES TO IMPROVE. 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 1042061

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| S CONCOMITANT MEDICAL DEVICES