BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 844230 · Received April 27, 2007

    Report

    Report Number
    9616695-2007-00040
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 5, 2007
    Manufacturer
    ABBOTT IRELAND VASCULAR DIVISION REG NO: 9616695
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, HOWEVER THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE XACT STENT (LOT # 35010-6G / CATALOG # 8209-01) REFERENCED IS BEING FILED UNDER MFR# 9616695-2007-00038. THE EMBOSHIELD (LOT # 421867 / CATALOG # E6190-01) REFERENCED IS BEING FILED UNDER MFR# 9616695-2007-00039.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL AND COMMON CAROTID STENTING PROCEDURE (2 STENTS PLACED), THE PATIENT SHOWED SIGNS OF LEFT SIDED NEGLECT OF HER UPPER AND LOWER EXTREMITIES. THE PATIENT ALSO COMPLAINED OF RIGHT MANDIBLE PAIN THAT WAS TEMPORARY. POST PROCEDURE CT SCAN OF THE BRAIN SHOWED A SMALL AREA OF INFARCTION. THE PATIENT SHOWED SIGNS OF IMPROVEMENT AT THE TIME OF DISCHARGE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. STUDY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM ABBOTT IRELAND VASCULAR DIVISION REG NO: 9616695 NA 35010-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| S EMBOSHIELD EMBOLIC PROTECTION DEVICE| XACT STENT| ANGIOMAX| MAVERICK AND VIATRAC BALLOONS