BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2143490 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04555
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. STENT: RX ACCULINK 10.0 X 40MM. OTHER: BIVALIRUDIN. EMBOLIC PROTECTION: RX ACCUNET. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT STROKE IS A KNOWN ADVERSE EVENT AS LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECT 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 AN XACT STENT AND AN RX ACCULINK STENT WERE IMPLANTED IN THE 55 MM LONG LESION IN THE LEFT INTERNAL / LEFT COMMON CAROTID ARTERY. POST STENT IMPLANTATION, THE PATIENT EXPERIENCED APHASIA, LOSS OF MOVEMENT ON THE RIGHT SIDE AND INATTENTION WHICH WAS DIAGNOSED AS A STROKE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY, CONDITION IMPROVED. 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 1011961

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S