BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 2940482 · Received January 30, 2013

    Report

    Report Number
    3003707320-2013-00001
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SUNEVA MEDICAL INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF ASSOCIATED BATCH MANUFACTURING RECORDS AND EVALUATION OF RETAINED LOT SAMPLES WERE CONDUCTED. PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH ALL WORK INSTRUCTIONS, MET ACCEPTANCE CRITERIA AT TIME OF RELEASE, AND CONTINUES TO MEET ACCEPTANCE CRITERIA. THIS IS THE FIRST REPORT OF LOSS OF VISION SINCE PRODUCT INCEPTION. ALL INJECTION LOCATIONS PROVIDED BY THE INJECTING AND TREATING PHYSICIANS ARE OFF-LABEL USE FOR ARTEFILL, OF WHICH THE INJECTING PHYSICIAN IS AWARE AND PER THE ARTEFILL INSTRUCTIONS FOR USE (IFU). THE ARTEFILL IFU INCLUDES "WARNINGS: ARTEFILL MUST NOT BE IMPLANTED INTO BLOOD VESSELS. IMPLANTATION OF ARTEFILL INTO BLOOD VESSELS MAY CAUSE VASCULAR OCCLUSION, INFARCTION, OR EMBOLIC PHENOMENA."

    Description of Event or Problem · 1

    THE PT CALLED SUNEVA MEDICAL FROM THE OPHTHALMOLOGIST'S OFFICE ON (B)(6) 2013 AFTER ARTEFILL INJECTION ON (B)(6) 2013. THE OPHTHALMOLOGIST STATED THAT ARTEFILL WAS INJECTED INTO THE PT'S BILATERAL CROW'S FEET ON (B)(6) 2013. IMMEDIATELY, POST PROCEDURE, THE PT COMPLAINED OF LOSS OF VISION IN THE RIGHT EYE TO THE NURSE AND THEN EXITED THE OFFICE. THE INJECTING PHYSICIAN WAS NOTIFIED SEVERAL HOURS LATER, AFTER WHEN HE CALLED THE OPHTHALMOLOGIST FOR AN URGENT REFERRAL. THE PT WAS TREATED BY THE OPHTHALMOLOGIST ON (B)(6) 2013. UPON EXAM, THE PT HAD VERY LITTLE ARTERIAL FLOW TO THE RIGHT EYE. PT WAS GIVEN IV FLUIDS IN AN ATTEMPT TO FLUSH THE MATERIAL OUT. THE ANTERIOR CHAMBER WAS THEN TAPPED TO LOWER INTRA-OCULAR PRESSURE. THE PT RECEIVED A HYPERBARIC OXYGEN TREATMENT ON (B)(6) 2013 WITH ADDITIONAL SCHEDULED ON (B)(6) 2013. THE OPHTHALMOLOGIST BELIEVES THE INJECTION IN THE CROW'S FEET (CANTHAL AREA) RESULTED IN ARTERIAL INJECTION CAUSING RETROGRADE FILLING INTO CENTRAL RETINAL VEIN, CAUSING LOSS OF VISION IN THE RIGHT EYE. THE INJECTING PHYSICIAN HAS REPORTED TO SUNEVA THAT THE PT WAS INJECTED WITH APPROXIMATELY 1CC OF ARTEFILL AROUND THE NECKLINES VERY SUPERFICIALLY, APPROXIMATELY 0.3CC AROUND EACH BROW AREA, 0.01CC IN THE RIGHT CANTHAL AREA, AND 0.01CC ON EACH SIDE OF THE NOSE. ALL STATED INJECTION LOCATIONS ARE OFF-LABEL USE FOR ARTEFILL OF WHICH THE INJECTING PHYSICIAN IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39963 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE (LMH) LMH SUNEVA MEDICAL INC. AF0508 F111073

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S