BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1962146 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00349
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. BIVALIRUDIN, EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4), LOT 0081151) THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF BRADYCARDIA, VASOCONSTRICTION, HYPOTENSION, CEREBROVASCULAR ACCIDENT AND TREATMENT WITH MEDICATIONS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PRODUCTS NO FAULT RISK ASSESSMENT REPORT. ADDITIONALLY, CEREBROVASCULAR ACCIDENT (STROKE), BRADYCARDIA, AND HYPOTENSION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS KNOWN POTENTIAL ADVERSE EFFECTS. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST SUCCESSFUL XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY THE PATIENT EXPERIENCED A STROKE WITH LEFT SIDED PARALYSIS AND NUMBNESS, AND SPEECH DIFFICULTY ASSOCIATED WITH CAROTID SPASM, HYPOTENSION, AND BRADYCARDIA. DOPAMINE WAS STARTED AND THE SYMPTOMS MARKEDLY IMPROVED, ALTHOUGH SOME NEUROLOGIC DEFICITS CONTINUE. 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 526793

    Patients

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