BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 7742747 · Received August 2, 2018

    Report

    Report Number
    9710154-2018-00045
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    August 2, 2018
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS, EXPECTED EVENTS OF UNILATERAL BLINDNESS, ANTERIOR SEGMENT ISCHAEMIA, AND CEREBRAL INFARCTION AND THE SERIOUS, UNEXPECTED EVENTS OF CATARACT, OPHTHALMOPLEGIA, PAPILLOEDEMA AND MICROPHTHALMOS WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE PERMANENT DISABILITY FROM ANTERIOR SEGMENT ISCHEMIA, CATARACT, MICROPTHALMOS AND UNILATERAL BLINDNESS, AND THE NEED FOR MULTIPLE MEDICAL AND SURGICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE INCLUDING HYPERBARIC OXYGEN, LOW[?]LEVEL LASER THERAPY, ANTERIOR CHAMBER PARACENTESIS OF LEFT EYE, METHYLPREDNISOLONE, ANTIPLATELET DRUGS, ORAL ANTIBIOTIC, ANTIEPILEPTIC DRUG, TOPICAL STEROID AND ANTIBIOTIC EYE DROPS, AND PLACEMENT OF AN ARTIFICIAL EYE. THE NON-SERIOUS, EXPECTED EVENTS OF IMPLANT SITE DISCOLOURATION AND INFLAMMATION, AND THE NON-SERIOUS, UNEXPECTED EVENTS OF NAUSEA, EYE PAIN, EYELID PTOSIS, DIZZINESS, FIXED PUPIL AND CONJUNCTIVAL OEDEMA WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. THE LIKELY ETIOLOGY OF THE EVENTS INCLUDES INTRAVASCULAR INJECTION WITH RETROGRADE MOVEMENT OF HA EMBOLI INTO THE CENTRAL RETINAL ARTERY, OPTHALMIC ARTERY, INTERNAL CAROTID ARTERY AND MIDDLE CEREBRAL ARTERIAL CIRCULATION. THE DIZZINESS AND NAUSEA WERE LIKELY ASSOCIATED WITH CEREBRAL INFARCTION. POTENTIAL CONTRIBUTORY FACTORS FOR THE REPORTED EVENTS INCLUDE POOR INJECTION TECHNIQUE WITH UNINTENTIONAL INJECTION INTO BLOOD VESSELS AND THE RICH COMMUNICATION BETWEEN THE EXTERNAL AND INTERNAL CAROTID VASCULAR NETWORK IN THE NASOLABIAL REGION. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION INFORMATION: EXEMPTION NUMBER E2015005 GALDERMA LABORATORIES, L.P. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF Q-MED AB (MANUFACTURER). - ATTACHMENT: [THANASARNAKSORN.2018.SEVERE VISION LOSS.PDF]

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT WHICH WAS DETECTED ON 24-JUL-2018 BY MED INFO. THIS CASE (REFERRED AS CASE 1 IN THE ARTICLE) REFERS TO A 36 YEARS-OLD FEMALE PATIENT. IN ADDITION, THIS CASE IS ALSO LINKED WITH TWO OTHER CASES THAT WERE INCLUDED IN THE SAME ARTICLE (LINKED CASES: (B)(4)). THE CITATION OF THE ARTICLE: THANASARNAKSORN W, COTOFANA S, RUDOLPH C, ET AL. SEVERE VISION LOSS CAUSED BY COSMETIC FILLER AUGMENTATION: CASE SERIES WITH REVIEW OF CAUSE AND THERAPY. J COSMET DERMATOL 2018; 00:1-7. A HEALTHY 36[?]YEAR[?]OLD WOMAN UNDERWENT NASAL AUGMENTATION WITH 1 ML OF HYALURONIC ACID (RESTYLANE, GALDERMA, UPPSALA, SWEDEN) INJECTION USING A BLUNT 27 G CANNULA UNDER INFRAORBITAL NERVE BLOCK WITH 1% XYLOCAINE ON BOTH SIDES. IMMEDIATELY AFTER COMPLETING THE INJECTION, THE PATIENT DEVELOPED SUDDEN[?]ONSET NAUSEA AND PAIN IN THE LEFT EYE. WITHIN 1 MINUTE, THE PATIENT OPENED HER EYES AND EXPERIENCED DECREASING VISION IN LEFT EYE WITH TOTAL OPHTHALMOPLEGIA AND COMPLETE PTOSIS, AS WELL AS DIZZINESS. SHE WAS REFERRED TO A HOSPITAL NEARBY. INITIAL PHYSICAL EXAMINATION YIELDED A VISUAL ACUITY OF 20/20 IN THE RIGHT EYE AND ONLY LIGHT PERCEPTION IN LEFT EYE. THE LEFT GLOBE WASVERY SOFT. THE LEFT EYE DEMONSTRATED A TOTAL OPHTHALMOPLEGIA WITH COMPLETE PTOSIS, A CLOUDY CORNEA, AND A FIXED, DILATED PUPIL. THE VIEW OF THE ANTERIOR CHAMBER, LENS, AND POSTERIOR SEGMENT COULD NOT BE VISUALIZED DUE TO CLOUDY CORNEA. PURPLISH DISCOLORATION WAS EVIDENT OVER HER LEFT ORBITAL AREA, FOREHEAD, AND NASAL BRIDGE. CT ANGIOGRAM SHOWED A LEFT OPHTHALMIC ARTERY OCCLUSION WITH AN ANTERIOR SEGMENT ISCHEMIA GRADE IV. AN MRI OF THE BRAIN AND ORBIT SHOWED A MULTIFOCAL RESTRICTED LESION AT THE CORTICAL GRAY MATTER OF THE BILATERAL FRONTAL, LEFT PARIETAL AND OCCIPITAL LOBES, CAUDATE NUCLEUS, PERIVENTRICULAR WHITE MATTER OF LEFT FRONTAL LOBE, AND EXTERNAL CAPSULE, WHICH LIKELY IS REPRESENTATIVE OF AN ACUTE INFARCTION DUE TO EMBOLIC PHENOMENON. LEFT OPTIC NERVE EDEMA WAS ALSO NOTED. SIX HOURS LATER, SHE WAS REFERRED TO OUR CENTER FOR COMPLICATION MANAGEMENT AND 3 ML (150 UNITS/ML) OF HYALURONIDASE WAS INJECTED AT THE NASAL AREA. HYPERBARIC OXYGEN THERAPY WAS ADMINISTERED AND LOW[?]LEVEL LASER THERAPY (LLLT) WAS GIVEN TO REDUCE INFLAMMATION ON THE LESION. ANTERIOR CHAMBER PARACENTESIS WAS DONE ON LEFT EYE. METHYLPREDNISOLONE AND ANTIPLATELET DRUGS WERE GIVEN IN ADDITION TO AN ORAL ANTIBIOTIC TO PREVENT SECONDARY INFECTION. AN ANTIEPILEPTIC DRUG WAS STARTED TO PREVENT SEIZURE. TOPICAL STEROID EYE DROP, AND TOPICAL ANTIBIOTIC EYE DROP WERE PROVIDED. A FOLLOW[?]UP OPHTHALMOLOGIC EXAMINATION IN THE FOLLOWING DAYS SHOWED A PROGRESSION OF THE CORNEAL EDEMA WITH A GRADUAL INCREASE IN CONJUNCTIVAL CHEMOSIS. ANTERIOR SEGMENT ISCHEMIA WAS SUSPECTED. VISUAL ACUITY OF LEFT EYE REMAINED LIGHT PERCEPTION. TWO MONTHS AFTERWARD, HER VISION IN THE LEFT EYE REMAINED LIMITED TO LIGHT PERCEPTION. THE LID PTOSIS AND OPHTHALMOPLEGIA WAS COMPLETELY RESOLVED. THE LEFT GLOBE EXHIBITED MICROPHTHALMIA. THE LEFT CORNEA BECAME MUCH CLEARER WITH MILD POSTERIOR STRIAE AND THE LEFT LENS SHOWED MODERATE CATARACT. SIX MONTHS LATER SHE RECEIVED A LEFT ARTIFICIAL EYE. IN CASE 1, THE TREATMENT WAS DELAYED AND THE OCULAR MASSAGE WAS NOT DONE. THE PATIENT SUFFERED FROM COMPLETE BLINDNESS AND SUBSEQUENT ARTIFICIAL EYE REPLACEMENT, WHICH EOM FUNCTION RETUNED AFTER 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583894 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention| S 1% XYLOCAINE