BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2193067 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05544
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. STENT: CORDIS PRECISE PRO 8 X 30. OTHER: HEPARIN. EMBOLIC PROTECTION: MO.MA 11 X 104. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF TRANSIENT ISCHEMIC ATTACK IS A KNOWN POTENTIAL ADVERSE EVENT AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED ADVERSE PATIENT EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH HEAVY CALCIFICATION, AFTER A NON-ABBOTT EMBOLIC PROTECTION DEVICE WAS INFLATED PROXIMAL TO THE LESION AND STENT PLACEMENT, THE PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACK WITH LEFT SIDED SYMPTOMS. THERE WAS A LARGE AMOUNT OF EMBOLIC MATERIAL NOTED IN THE EXTRACTION SYRINGE AND EMBOSHIELD NAV6 EMBOLIC PROTECTION FILTER. THE PATIENT'S SYMPTOMS LASTED 60 SECONDS AND RESOLVED. THE PATIENT WAS DISCHARGED HOME ONE DAY AFTER THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATIONN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0110351

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention