BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2033034 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02137
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    December 23, 2010
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF STROKE AND HEMORRHAGE ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE, AS A KNOWN POTENTIAL ADVERSE EFFECTS. 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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF TRANSIENT ISCHEMIC ATTACK (TIA) IS A KNOWN ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT DID NOT EXPERIENCE A CEREBROVASCULAR ACCIDENT. ALTHOUGH THE PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE, SYMPTOMS RESOLVED WITHIN ONE HOUR AND THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST XACT STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT ARM AND SPEECH DIFFICULTY. CT SCAN OF THE HEAD REVEALED AN ACUTE LEFT FRONTAL HEMISPHERE SUBARACHNOID HEMORRHAGE. THE SYMPTOMS RESOLVED WITHIN AN HOUR OR TWO. THE PATIENT'S COUMADIN WAS DISCONTINUED. THERE WAS NO REPORTED TREATMENT PROVIDED.. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME TEN DAYS AFTER THE PROCEDURE. 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 0100161

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| S COUMADIN