BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LIDOCAINE

    MDR report key: 7742755 · Received August 2, 2018

    Report

    Report Number
    9710154-2018-00047
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    August 2, 2018
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    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, BLURRED VISION AND RETINAL ARTERY OCCLUSION, AND THE SERIOUS, UNEXPECTED EVENTS OF OPHTHALMOPLEGIA AND OPTIC NEUROPATHY WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE THE PERMANENT DISABILITY OF UNILATERAL BLINDNESS AND BLURRED VISION AND THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE INCLUDING HYALURONIDASE, TRANSDERMAL NITROGLYCERIN, INTRAVENOUS ANTIBIOTIC, SYSTEMIC STEROIDS, HYPERBARIC OXYGEN THERAPY AND PULSED ELECTROMAGNETIC FREQUENCY. THE NON-SERIOUS, EXPECTED EVENTS OF PALLOR, SKIN DISCOLOURATION AND SWELLING, AND THE NON-SERIOUS, UNEXPECTED EVENTS OF HEADACHE AND EYELID PTOSIS WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. THE LIKELY ETIOLOGY OF THE EVENTS INCLUDES INTRAVASCULAR INJECTION OF THE SUPERFICIAL TEMPORAL ARTERY WITH RETROGRADE MOVEMENT OF HA EMBOLI INTO THE SUPRAORBITAL ARTERY, OPHTHALMIC ARTERY, AND CENTRAL RETINAL ARTERIAL CIRCULATION. POTENTIAL CONTRIBUTORY FACTORS FOR THE REPORTED EVENTS INCLUDE POOR INJECTION TECHNIQUE WITH UNINTENTIONAL INJECTION INTO BLOOD VESSELS, AND ANASTOMOSIS OF THE SUPERFICIAL TEMPORAL AND SUPRAORBITAL ARTERIES. 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 5 IN THE ARTICLE) REFERS TO A (B)(6) 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 (B)(6) OLD WOMAN WITH A BONE DEFORMITY ON THE LEFT SIDE OF HER FOREHEAD UNDERWENT FILLER AUGMENTATION IN THE LEFT SIDE OF HER FOREHEAD ON THE PERIOSTEUM WITH 1 ML OF HYALURONIC ACID (RESTYLANE WITH LIDOCAINE, GALDERMA) INJECTION BY A 25 G BLUNT CANNULA. THE PATIENT DEVELOPED A SEVERE HEADACHE, SKIN BLANCHING AND BLURRED VISION IN HER LEFT EYE IMMEDIATELY AFTER THE INJECTION. WITHIN 15 MINUTES AFTER THE INCIDENT, WITHIN 15 MINUTES AFTER THE INCIDENT, THE PATIENT RECEIVED 9 ML OF AN INTRALESIONAL HYALURONIDASE (150 UNITS/ML) INJECTION AND 8 ML OF A RETROBULBAR HYALURONIDASE (150 UNITS/ML) INJECTION BY THE DOCTOR WHO PERFORMED FILLER AUGMENTATION. A NITROGLYCERIN TRANSDERMAL PAD WAS APPLIED ON THE CHEST THEN OCULAR MASSAGE AND REBREATHING IN A PLASTIC BAG WERE PERFORMED DURING THE PATIENT REFERRAL. INITIAL PHYSICAL EXAMINATION SHOWED A WELL[?]DEMARCATED PURPLISH DISCOLORATION OF THE SKIN ALONG THE TERRITORY OF THE LEFT SUPRAORBITAL AND SUPRATROCHLEAR ARTERIES AND UPPER EYELID AND MILD SWELLING AND PTOSIS OF THE LEFT UPPER EYELID. THE RIGHT EYE PUPIL WAS 2.5 MM AND WAS REACTIVE TO LIGHT, WHILE THE LEFT EYE PUPIL WAS 3 MM AND SLOWLY REACTS TO LIGHT. ON ASSESSMENT OF VISUAL ACUITY, THE LEFT EYE WAS LIMITED TO ONLY LIGHT PERCEPTION. MRA AND MRI OF THE BRAIN SHOWED A SMALL SUBACUTE INFARCTION AT LEFT TEMPORAL LOBE, SUGGESTIVE OF AN ACUTE LEFT OPTIC NEUROPATHY AT THE INFRAORBITAL SEGMENT WITH RESTRICTED DIFFUSION, WHICH WAS CONSIDERED TO BE DUE TO AN ISCHEMIC CAUSE. THE ORIGIN OF THE OPHTHALMIC ARTERIES WAS PATENT WITH LIMITED EVALUATION OF THE DISTAL PART. THE PATIENT WAS DIAGNOSED WITH A LEFT OPHTHALMIC ARTERY OCCLUSION AND PRESCRIBED AN INTRAVENOUS ANTIBIOTIC, SYSTEMIC STEROID AND HYPERBARIC OXYGEN THERAPY. PULSED ELECTROMAGNETIC FREQUENCY WAS APPLIED TO REDUCE THE PAIN. PTOSIS AND EOM FUNCTION PARTIALLY IMPROVED 20 DAYS AFTER INITIAL INJURY. OPHTHALMOPLEGIA WAS ALMOST FULLY RECOVERED AT 30 DAYS AFTER INITIAL INJURY; HOWEVER, THE VISUAL ACUITY OF THE LEFT EYE WAS STILL LIMITED TO LIGHT PERCEPTION. IN CASE 5, DESPITE IMMEDIATELY INJECTING HYALURONIDASE INTO THE RETROBULBAR SPACE, THE VISUAL DEFECT WAS NOT REVERSED. THIS COULD BE DUE TO THE HYALURONIC ACID ALREADY EMBOLIZING IN THE CENTRAL RETINAL ARTERY IN THE AREA OF THE OPTIC SHEATH, WHICH HYALURONIDASE CANNOT PASS THROUGH. FURTHERMORE, TOO MUCH VOLUME OF HYALURONIDASE INJECTION (8 ML IN THIS CASE) MAY HAVE RESULTED IN A MAGNIFICATION OF PRESSURE EFFECT, WHICH COULD HAVE FORCED THE HYALURONIC ACID FURTHER INTO THE CENTRAL RETINAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583903 RESTYLANE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S