BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 1040029 · Received May 7, 2008

    Report

    Report Number
    9616695-2008-00066
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FILTER MATERIAL DETACHMENT. TIME OF MALFUNCTION/AE: DURING PROCEDURE. SYMPTOMS/AE: FILTER MATERIAL REMAINS IN ARTERY. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE FILTER MATERIAL SHEARED OFF AND REMAINS THE ARTERY. THE EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD) WAS SUCCESSFULLY DEPLOYED AND THE STENTING PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY. AFTER THE EPD WAS REMOVED, A "WHITE SPECK" WAS SEEN FLUOROSCOPICALLY IN THE CAROTID ARTERY AND WAS ASSUMED TO BE FILTER MATERIAL. THE EPD WAS EXAMINED AND WAS FOUND TO HAVE SOME FILTER MATERIAL MISSING. NO INTERVENTION WAS PERFORMED AND THE FILTER MATERIAL REMAINS IN THE ARTERY. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability XACT STENT| EMBOSHIELD 5.0| BARE WIRE