BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1962626 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00367
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    September 10, 2010
    Report Date
    December 27, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. NEUROLOGICAL DEFICIT AND THROMBOSIS ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS OF THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. OTHER: BIVALIRUDIN EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19, LOT #0050351). THE STENT REMAINS INSIDE THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED NEUROLOGICAL CHANGES AND CHANGES IN THE LEFT UPPER EXTREMITY. CT SCAN OF THE HEAD WAS NEGATIVE. ULTRASOUND SHOWED A PATENT STENT. THE PATIENT WAS DIAGNOSED WITH A LEFT CEPHALIC VEIN THROMBOSIS, BUT DID NOT RECEIVE MEDICAL THERAPY OTHER THAN PHYSICAL THERAPY. THE PATIENT WAS DISCHARGED THE DAY AFTER THE CAROTID PROCEDURE. THE PATIENT'S CONDITION HAS IMPROVED WITH PHYSICAL THERAPY AND HOME THERAPY. 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 00629-61

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability