MAUDE Adverse Event Report: MERZ AESTHETICS, INC RADIESSE DERMAL FILLER; INJECTABLE IMPLANT

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Edema (1820); Embolism (1829); Eye Injury (1845); Headache (1880); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Neuropathy (1983); Occlusion (1984); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Vomiting (2144); Test Result (2695)

Event Type  Injury  

Event Description

On (b)(4) 2015, merz received a literature case report from (b)(6).According to the case report, a healthy, (b)(6) female patient developed choroid vascular occlusion and ischaemic optic neuropathy after facial radiesse (1.5 ml, calcium hydroxyapatite (caha) injection).The patient without any history of ocular and systemic disease received caha filler injections for cosmetic nose augmentation.Multiple injections along midline of the nasal dorsum from nasal tip to glabella were performed under local anaesthesia.Ten minutes after the procedure, she developed nausea, vomiting, headache, ptosis, and left periorbital pain.After 30 minutes, she complained of progressively blurring vision in the left eye.Best-corrected visual acuity (bcva) in her left eye was 30 cm ahead of hand motion.Skin necrosis developed over the nasal dorsum, glabellar region, and left forehead.Left exotropia was noted in primary gaze.Limitations in adduction, supraduction, and infraduction of the left eye were also observed.Slit lamp examination of the left eye revealed a pink conjunctiva, a clear cornea, a mild anterior chamber reaction, a sluggish pupillary light reflex, and a semi-dilated pupil.A positive relative afferent pupillary defect was observed in the left eye.Intraocular pressure was normal in both eyes.Fundus examination revealed optic disc oedema and some linear whitish opacities over the superior and temporal sites in the left eye, suggesting multiple caha emboli in the choroid vessels.Optical coherence tomography (oct) revealed disc oedema without macular oedema in the left eye.Fluorescein angiography revealed neither delayed filling nor hypofluorescence in the left eye.Visual field testing revealed an inferior altitudinal visual field defect in the left eye.Measurement of the visual evoked potential (vep) showed a decreased amplitude and marked delay in the appearance of peaks.Electroretinography (erg) showed a normal waveform.All examinations were normal in the right eye.Orbital computed tomography (ct) demonstrated high-density deposits in the nose region and left medial orbital cavity.No evident lesion was noted on brain magnetic resonance imaging (mri).Alprostadil and dextran were administered for improving blood supply.Moreover, ten sessions of hyperbaric oxygen therapy were administered.One month later, the visual acuity in her left eye improved to 6/60.A pale disc was observed, with persistent plaque occlusions in the choroid vessels.The authors state that in the present case, multiple emboli localised on the choroidal layer without retinal vessel occlusion, resulting in normal erg waveform.However, poor vision, a positive relative afferent pupil defect (rapd) sign, and a pale, swollen disc were present.Visual field testing showed an inferior altitudinal visual field defect.The authors postulate that the caha emboli migrated via the dorso-nasal artery back to the main ciliary arteries and occluded the short posterior ciliary arteries, which supply the superior nasal choroid and the optic nerve.Subsequently, ischaemic optic neuropathy developed and caused poor vision, a positive rapd sign, a pale, swollen disc, and an abnormal waveform on vep.Furthermore, the authors first postulated that the occluded vessel was haller's layer because the distribution pattern of affected vessels was consistent with the haller's layer distribution pattern.The emboli moved back to branches supplying the oculomotor nerve, causing blepharoptosis and ophthalmoplegia.This is compatible with the ct findings.The ptosis and limitation in supraduction subsided gradually.The authors postulate that the superior division of the oculomotor nerve innervating the levator and superior rectus muscles recovered early.

Manufacturer Narrative

(b)(6).

• Brand Name: RADIESSE DERMAL FILLER
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ AESTHETICS, INC; franksville WI
• Manufacturer Contact: t watson ; 4133 courtney road; suite 10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4746022
• MDR Text Key: 5824964
• Report Number: 2135225-2015-00029
• 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,Literature,Company Representative
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2015
• 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: Initial
• Patient Sequence Number: 1
• Treatment: LOCAL ANAESTHESIA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR