BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1850776 · Received September 28, 2010

    Report

    Report Number
    3004742046-2010-00449
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 3, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRADYCARDIA, HYPOTENSION AND PLAQUE ARE KNOWN AS ADVERSE EVENTS LISTED IN THE XACT INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER STENT POST-DILATATION WAS PERFORMED IN THE LEFT INTERNAL CAROTID ARTERY, BRADYCARDIA AND HYPOTENSION OCCURRED, TREATED WITH INTRAVENOUS FLUID BOLUS. AFTER REMOVAL OF THE FILTER A 75% NARROWING IN THE COMMON CAROTID ARTERY WAS SEEN AT THE PROXIMAL TIP OF THE STENT, WHICH WAS NOT SEEN PRIOR TO STENT DEPLOYMENT. INTRAARTERIAL NITROGLYCERIN WAS GIVEN, HOWEVER, THERE REMAINED "A SIGNIFICANT APPLE-CORE LESION OF 75%" THAT APPEARED TO BE PHYSIOLOGICALLY SIGNIFICANT AND THAT MAY HAVE BEEN CAUSED BY THE STENT. THE LESION WAS BELIEVED TO BE UNDERLYING PLAQUE. ANOTHER XACT STENT WAS IMPLANTED OVERLAPPING THE EDGE OF THE FIRST STENT, RESULTING IN 0% RESIDUAL STENOSIS AND BRISK DISTAL FLOW. NEUROLOGIC EXAMINATION WAS NORMAL AND UNCHANGED. BRADYCARDIA AND HYPOTENSION CONTINUED POST PROCEDURE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0050761

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention EMBOSHIELD NAV6| HEPARIN