BEUDAMED
    FDA Adverse Event Other Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 844325 · Received April 30, 2007

    Report

    Report Number
    9616695-2007-00035
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    February 20, 2006
    Report Date
    March 31, 2007
    Manufacturer
    ABBOTT IRELAND VASCULAR DIVISION
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFORMATION. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE. IN 2006: FINAL CEC ADJUDICATION WAS REPORTED AS TIA. IN 2007: FINAL CEC ADJUDICATION WAS REPORTED AS STROKE.

    Description of Event or Problem · 1

    IN 2006, A PHYSICIAN SUCCESSFULLY DEPLOYED AN EMBOSHIELD INTO THE RIGHT INTERNAL CAROTID ARTERY, THE XACT STENT WAS SUCCESSFULLY POSITIONED AND DEPLOYED; POST-STENT DILATATION WAS PERFORMED WITH ANOTHER BRAND OF BALLOON; THE EMBOSHIELD WAS SUCCESSFULLY RETRIEVED. THE NEXT DAY, ON HIS WAY HOME FROM THE HOSPITAL, THE PT EXPERIENCED A TIA WITH DURATION LESS THAN TWENTY-FOUR HOURS. NINE DAYS LATER, THE PT EXPERIENCED A SUDDEN ONSET OF SYMPTOMS: DIZZINESS, SLURRED SPEECH, BILATERAL WEAKNESS IN THE UPPER AND LOWER EXTREMITIES, AND INABILITY TO WALK. THESE SYMPTOMS LASTED FOR ABOUT ONE HOUR. TWO MONTHS LATER, THE PT REPORTED TREMBLING IN THE RIGHT ARM AND LEG AND DIFFICULTY SPEAKING. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other ASPIRIN 81 MG| CLOPIDOGREL 75MG