BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1990919 · Received February 15, 2011

    Report

    Report Number
    2024168-2011-00919
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. EMBOLISM AND STROKE ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE 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 TWO DAYS POST LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH A XACT STENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER SHE FELL OVER HER WALKER AND SUSTAINED A SPINAL COMPRESSION FRACTURE. ON (B)(6) 2010, NINE DAYS POST STENT IMPLANTATION, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS WHICH WAS FELT TO BE EMBOLIC BY THE NEUROLOGIST. MRI OF THE HEAD SHOWED ACUTE FOCI OF INFARCT. CAROTID ULTRASOUND REVEALED WIDELY PATENT BILATERAL CAROTIDS. PLAVIX AND ASPIRIN WERE CONTINUED. LOVENOX WAS ADDED UNTIL THERAPEUTIC WHEN COUMADIN COULD BE STARTED. THE PATIENTS CONDITION RESOLVED TO BASELINE ON (B)(6) 2011 AND THE PATIENT WAS DISCHARGED TO A SKILLED REHABILITATION FACILITY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0072261

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R| S