BEUDAMED
    FDA Adverse Event Other Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 700352 · Received April 13, 2006

    Report

    Report Number
    9616695-2006-00037
    Event Type
    Other
    Date Received
    April 13, 2006
    Date of Event
    March 24, 2006
    Report Date
    March 29, 2006
    Manufacturer
    ABBOTT VASCULAR DEVICES IRELAND, LTD.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT PLACEMENT OF XACT CAROTID STENT IN THE LEFT INTERNAL CAROTID ARTERY ON 03/24/2006. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED NEUROLOGICAL SYMPTOMS AND IT WAS DETERMINED THAT THE PATIENT HAD A STROKE. THE PATIENT WAS HOSPITALIZED AND DISCHARGED TO HOME 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM FGE ABBOTT VASCULAR DEVICES IRELAND, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| O