BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 2040442 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02403
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE XACT STENT IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF ALLERGIC REACTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST EMBOSHIELD USAGE AND XACT STENTING PROCEDURE IN THE RIGHT CAROTID ARTERY, THE PATIENT EXPERIENCED A PAINFUL, RED RASH ON HIS TRUNK, BACK, ARMS AND UPPER LEGS. THE PHYSICIAN ASSISTANT FEELS THAT THE RASH IS PROBABLY RELATED TO THE PATIENT'S MEDICATIONS AND NOT THE DEVICES. THE PATIENT IS CURRENTLY BEING TREATED WITH MEDICATION FOR THE REACTION. THE PATIENT'S CONDITION IS CONTINUING BUT IMPOVED. THERE WAS NO ADDITION INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention XACT STENT