BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4273124 · Received November 18, 2014

    Report

    Report Number
    2135225-2014-00082
    Event Type
    Injury
    Date Received
    November 18, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE RADIESSE LOT WAS NOT REVIEWED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    LITERATURE ARTICLE BY HSIAO AND HUANG: PARTIAL VISION RECOVER AFTER IATROGENIC RETINAL ARTERY OCCLUSION (RAO). BMC OPHTHALMOLOGY 2014 14:120. CASE PRESENTATION: A (B)(6) WOMAN SOUGHT TREATMENT IN THE EMERGENCY DEPARTMENT REPORTED SUDDEN VISION LOSS IN HER LEFT EYE. FOUR HOURS PREVIOUSLY, SHE RECEIVED VAGINAL PLASTIC SURGERY AND CAHA FILLER INJECTION INTO THE GLABELLA REGION BY A LOCAL PLASTIC SURGEON UNDER GENERAL ANESTHESIA. AFTER WAKING UP, SHE NOTED VISION LOSS IN HER LEFT EYE, AND WAS IMMEDIATELY TRANSFERRED TO (B)(6) HOSPITAL, (B)(6). THE INITIAL BEST-CORRECTED VISUAL ACUITY (BCVA) AT OUR EMERGENCY DEPARTMENT WAS HAND MOTION AT 15 CM IN THE LEFT EYE AND 1.0 IN THE RIGHT. THE LEFT PUPIL WAS DILATED WITH A POSITIVE RELATIVE AFFERENT PAPILLARY DEFECT. THERE WAS NEITHER OPHTHALMOPLEGIA NOR STRABISMUS. SLIT LAMP EXAMINATION SHOWED MULTIPLE EMBOLI ALONG THE CONJUNCTIVAL VESSELS. FUNDOSCOPY IN THE RIGHT EYE (OD) REVEALED NORMAL FINDINGS, WHILE THE LEFT (OS) SHOWED MULTIPLE EMBOLI IN THE WHOLE CHOROIDAL LAYER. THE CORRESPONDING SPECTRAL-DOMAIN OCT SHOWED NORMAL CHOROIDAL VASCULARITY IN THE RIGHT EYE. IN THE LEFT EYE, MULTIPLE HYPER-REFLECTIVE DEPOSITIONS, WHICH RESULTED IN DARK ACOUSTIC SHADOWS IN THE RETINAL LAYER, WERE FOUND. CLOSE-UP IMAGING REVEALED DISTAL RAOS. MAGNETIC RESONANCE IMAGING (MRI) SHOWED NO EVIDENCE OF ACUTE BRAIN INFARCTION, HOWEVER, THERE WERE HIGH-ATTENUATION MATERIALS AROUND THE GLABELLA REGION, WHICH WERE COMPATIBLE WITH THE CAHA FILLER INJECTION. FUNDUS FLUORESCEIN ANGIOGRAPHY (FAG) OBTAINED ON THE SECOND HOSPITAL DAY SHOWED MULTIPLE ABSENCES OF RETINAL PERFUSION IN THE ARTERIOVENOUS PHASE AND FLUORESCEIN LEAKING OUT OF THE OCCLUSIVE RETINAL ARTERY WAS FOUND IN THE LATE PHASE. UNDER THE DIAGNOSIS OF IATROGENIC RAO, THE THERAPIES WERE ADMINISTERED TO SHORTEN THE ISCHEMIC PERIOD ON THE BASIS OF THE (B)(6) FOR LYSIS IN THE EYE ((B)(6)) GUIDELINES, INCLUDING TOPICAL AND SYSTEMIC INTRAOCULAR PRESSURE LOWERING AGENTS, ISOVOLEMIC HEMODILUTION, GLOBE MASSAGE, AND ANTICOAGULATION WITH ACETYLSALICYLIC ACID. IN ADDITION, CARBOGEN INHALATION AND ORAL CORTICOSTEROIDS WERE ALSO PROVIDED. DESPITE THE TREATMENT, PROGRESSIVE BLURRED VISION WAS STILL FOUND IN THE FOLLOWING FEW HOURS. INTRA-ARTERIAL FIBRINOLYSIS USING RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR WAS NOT PERFORMED BECAUSE OF HIGHER RATES OF ADVERSE SIDE EFFECTS. AN ALTERNATIVE TREATMENT OPTION, HBOT, WAS PERFORMED. OUR PATIENT RECEIVED 100% OXYGEN VIA A FACE MASK AT A MAXIMUM AMBIENT PRESSURE OF 2.5 ATMOSPHERES ABSOLUTE. THE PROTOCOL FOR THE TREATMENT WAS 10 MINUTES OF COMPRESSION, FOLLOWED BY A HYPERBARIC PHASE OF 60 MINUTES, AND 15 MINUTES OF DECOMPRESSION. THE TREATMENT SCHEDULE WAS HBOT 3 TIMES WITHIN THE INITIAL 24 HOURS, AND 3 MORE TREATMENTS WITHIN THE FOLLOWING 72 HOURS, FOR A TOTAL OF 6 TREATMENTS. CONJUNCTIVAL BIOPSY (OS) WAS PERFORMED LATER, WHICH REVEALED MULTIPLE CALCIFIED FOREIGN BODIES IN THE VESSEL LUMENS. THE VISUAL ACUITY REMAINED STABLE AFTER THE TREATMENTS, AND THE PATIENT WAS DISCHARGED. THREE MONTHS AFTER ONSET, THE BCVA IMPROVED FROM HAND MOTION AT 15 CM TO 0.1 (OD). FUNDOSCOPY IN THE LEFT STILL SHOWED MULTIPLE EMBOLI IN RETINAL VESSELS. FOLLOW-UP FLUORESCEIN ANGIOGRAPHY (FAG) SHOWED IMPROVED RETINAL CIRCULATION AND DECREASED RETINAL VESSEL LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744530 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O GENERAL ANESTHESIA