BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1894987 · Received November 5, 2010

    Report

    Report Number
    3004742046-2010-00519
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF HYPOTENSION, VISUAL DISTURBANCES, AND BRADYCARDIA ARE KNOWN ADVERSE EVENTS LISTED IN THE XACT INSTRUCTIONS FOR USE AS NO FAULT COMPLICATIONS. IN THIS CASE, THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION. 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 TRIAL THAT POST A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH AN XACT STENT, THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA WHICH WERE TREATED WITH ISUPREL, NEOSYNEPHRINE AND DOPAMINE. THE EVENT RESOLVED AND ON (B)(6) 2010, THE PATIENT WAS DISCHARGED TO HOME. ON (B)(6) 2010, THE PATIENT EXPERIENCED RIGHT SIDED BLURRED VISION AND WAS REHOSPITALIZED. THE EVENT WAS DIAGNOSED AS A TRANSIENT ISCHEMIC ATTACK AND WAS TREATED WITH AN EXTRA DOSE OF PLAVIX 150 MG. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION, TREATED WITH CIPRO; ASYMPTOMATIC BRADYCARDIA, FELT TO BE DUE TO A NEW MEDICATION; ANEMIA POSSIBLY DUE TO A GASTROINTESTINAL BLEED, TREATED WITH A BLOOD TRANSFUSION; AND HYPOTENSION, TREATED WITH FLUID. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9051551

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R EMBOSHIELD NAV 6 (22438-19, LOT # 0072051)| BIVALIRUDIN| ZIAC