BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2000934 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01161
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 2, 2011
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ADDITIONALLY, HYPOTENSION IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. 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 AN XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY. DURING POST DILATATION, USING A VIATRAC BALLOON,THE PATIENT EXPERIENCED HYPOTENSION THAT CONTINUED POST PROCEDURE AND WAS TREATED WITH NEOSYNEPHRINE. NEOSYNEPHRINE WAS INFUSED FOR ONE DAY AND NO ORAL MEDICATION WAS GIVEN FOR HYPOTENSION. THE PATIENTS CONDITION IMPROVED ALTHOUGH BLOOD PRESSURE WAS STILL LOW (92/47) AT THE TIME OF DISCHARGE ON (B)(6) 2011. 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 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R DILATATION CATHETER: VIATRAC 4.0 X 20 AND 5.0 X 20