BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1902308 · Received November 11, 2010

    Report

    Report Number
    3004742046-2010-00531
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 18, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THE REPORTED HOSPITALIZATION WAS IN RESPONSE TO THE PT SYMPTOM. INFO AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFO, A DEFINITIVE CAUSE FOR THE REPORTED PT ADVERSE EFFECT 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. HYPOTENSION MAY OCCUR DURING CAROTID INTERVENTIONAL PROCEDURES AND IT IS ANTICIPATED RESPONSE OF THE HUMAN BODY TO STIMULUS OF THE CAROTID BULB.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PT DEVELOPED HYPOTENSION THAT REQUIRED A DOPAMINE INFUSION FOR TWO DAYS FOLLOWED BY ORAL MEDICATIONS, MIDODRINE AND FLORINEF TO INCREASE BLOOD PRESSURE. THE PT'S CONDITION WAS CONSIDERED RESOLVED AND THE PT WAS DEEMED STABLE TO BE DISCHARGED HOME ON (B)(6) 2010, ALTHOUGH THE PT CONTINUED TO HAVE SOME DIZZINESS, BUT WAS ABLE TO AMBULATE INDEPENDENTLY. THE PT'S BLOOD PRESSURE HAD IMPROVED WITH ORTHOSTATIC CHANGED THAT WERE LESS PRONOUNCED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0021751

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R BIVALIRUDIN| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| (PART 22438-19, LOT 0082551)