MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the events, necrosis and ophthalmoplegia, were deemed to meet serious injury criteria of hospitalization.The device history record could not be reviewed as the lot number was not reported.Citation: liu, y.-c., tsai, m.-f., & chen, y.-f.(2020).Near complete recovery of visual acuity after calcium hydroxylapatite injection-related vision loss.Annals of plastic surgery, 84.Doi: 10.1097/sap.0000000000002168.

Event Description

This literature report from (b)(6) concerns a (b)(6)-year-old female patient.She was injected with radiesse® into the dorsum of the nose, at a private cosmetic clinic.The patient underwent the filler treatment for augmentation of the nasal dorsum in the previous past.The patient had no systemic diseases.Immediately after the injection with radiesse®, the patient experienced severe pain from the nasal dorsum to the left eye and sudden onset of bilateral vision impairment.Blurring of vision occurred, and she experienced nausea with vomiting.The patient was subsequently transferred to the emergency department.On arrival, initial physical and ophthalmic examination was performed.Ecchymosis was observed over the nasal dorsum.Vision acuity was decreased; 20/50 in the right eye and 20/63 in the left eye, and obvious impaired adduction of the left eye was noted, implying ophthalmoplegia.Blepharoptosis was not observed.Examination of the fundus showed no evidence of retinal vessel occlusion.Provisional diagnosis of central retinal arterial occlusion was made.The patient received treatment with prostaglandin e1 (pge1; intravenous infusion with 80 mg every day) and dexamethasone (intravenous, 5 mg every 12 hours) and was hospitalized.On the second day after the emergency treatment, improvement in visual acuity was observed to 20/20 in the right eye and 20/40 in the left eye.Slit lamp examination showed calcium hydroxylapatite particle over the nasal side of the conjunctiva of the left eye.Ophthalmoplegia persisted in the left eye, with impairment of adduction.Fluorescence angiography and fundus examination were performed again, the results of which were within normal limits.Visual acuity improved to 20/20 in the left eye on the fourth day.Prostaglandin e1 was discontinued, and oral form of the steroid (dexamethasone, 1mg, oral form twice daily for 5 days) was advised.Magnetic resonance imaging was performed on the sixth day, which revealed hyperintensity of the superior oblique and medial rectus muscles, indicating the inflammatory process.Necrosis gradually developed in the skin of the forehead on the sixth day, and the gentamycin ointment for the wound care was used.Hyperbaric oxygen therapy was initiated on the seventh day after which the patient was discharged.Improvement in the skin lesion was noticed after the hyperbaric oxygen therapy.During the regular out-patient clinic follow-up, the calcium hydroxylapatite particle was visible over the conjunctiva of the left eye.Gradual improvement was seen in ophthalmoplegia, which resolved finally after 2 months.Follow up photograph taken after 2 years showed no limitation in the extraocular movement of the left eye with minimal scar formation.Due to the provided information, the outcome of the event "necrosis" was considered as resolved with sequelae, and of all other events as resolved.In the opinion of the authors, considering the magnetic resonance imaging and fundus examination results, the main mechanism of the patient's vision loss was filler embolism-related ischemia of the anterior segment of the eyeball, which further caused inflammation, rather than direct, irreversible retina ischemia.Embolism was mainly in the long posterior ciliary artery and anterior ciliary artery, which supply the anterior segment of the eye, rather than the central retinal artery.Therefore, the macula was spared from the damage, facilitating gradual recovery of vision after resolution of the inflammation.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 9598115
• MDR Text Key: 189479883
• Report Number: 3013840437-2020-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR