BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1181170 · Received September 30, 2008

    Report

    Report Number
    9616695-2008-00139
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    July 30, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY REPORT. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE DEVICE AS LISTED IN THE INSTRUCTIONS FOR USE. THERE WAS NO DEVICE MALFUNCTION REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION. TIME OF AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT POST A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE PATIENT WAS TREATED WITH A DOPAMINE DRIP. ONE DAY POSTPROCEDURE, THE DOPAMINE WAS DISCONTINUED. TWO DAYS POSTPROCEDURE, THE PATIENT WAS DISCHARGED TO HOME WITH ORDERS TO TAKE ORAL PSEUDOEPHEDRINE. THE PHYSICIAN NOTE STATES, "BARORECEPTOR DYSFUNCTION". ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 36035-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEPARIN| XACT STENT| EMBOSHIELD EMBOLIC PROTECTION DEVICE