BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2445104 · Received February 9, 2012

    Report

    Report Number
    2024168-2012-00800
    Event Type
    Death
    Date Received
    February 9, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2011=EMBOLIC PROTECTION DEVICE: EMBOSHIELD NAV6; HEPARIN. (B)(6) 2012=ASPIRIN, COUMADIN, PLAVIX. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF HYPOTENSION, DEATH AND HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE PATIENT EFFECTS 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 ON (B)(6) 2011, THE PATIENT UNDERWENT AN XACT STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT EXPERIENCED HYPOTENSION WHEN THE BALLOON WAS INFLATED PRIOR TO THE STENT PLACEMENT. NEO-SYNEPHRINE 100 MG INTRAVENOUS PUSH WAS GIVEN. THE PATIENT'S BLOOD PRESSURE WAS BASELINE POST PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. ON (B)(6) 2012, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM UNRESPONSIVE AND EXPIRED DUE TO A CATASTROPHIC MULTIFOCAL INTRACEREBRAL HEMORRHAGE CENTERED IN THE LEFT CEREBRAL AREA. THE PATIENT HAD BEEN ON ASPIRIN, COUMADIN AND PLAVIX. 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 1041361

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death