BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2980725 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01148
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    June 7, 2012
    Report Date
    February 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PATIENT AGE ESTIMATED AS (B)(6). PATIENT GENDER ESTIMATED AS MALE. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, NEUROLOGICAL DEFICIT DYSFUNCTION, AND TRANSIENT ISCHEMIC ATTACK (TIA) ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE ACCUNET, ACCULINK AND XACT REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THIS STUDY AIMS TO REVIEW RETROSPECTIVELY THE RECORDS OF PATIENTS TREATED WITH CAROTID ARTERY STENTING (CAS) TO INVESTIGATE THE POTENTIAL CORRELATIONS BETWEEN CLINICAL VARIABLES, DISTAL PROTECTION FILTER (DPF) TYPE AND CHARACTERISTICS, AND 30-DAY PERI-/POSTPROCEDURAL OUTCOMES. THIS IS A MULTICENTER, SINGLE-ARM, NONRANDOMIZED RETROSPECTIVE STUDY OF (B)(4) PATIENTS WHO UNDERWENT FILTER-PROTECTED CAS BETWEEN (B)(4) 2000 AND (B)(4) 2011. ANALYSIS OF PERI-/POSTPROCEDURAL COMPLICATIONS INCLUDED: (B)(4). IT WAS NOTED THAT SYMPTOMATIC PATIENTS WHO UNDERWENT CAS WITH A CLOSED CELL STENT (ABBOTT VASCULAR XACT STENT WAS INCLUDED) HAVE A HIGHER RISK OF AE AND PERI-/POSTPROCEDURAL STROKE. THE ACCUNET AND EMBOSHIELD WERE AMONG THE SIX DIFFERENT TYPES OF FILTERS USED. THE ACCULINK STENT AND XACT STENT WERE AMONG THE STENT TYPES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85380 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability