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 Stroke/CVA (1770); Headache (1880); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Loss of Vision (2139); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Merz north america assessment: this case was reported in literature without mentioning a brand name.Since the concerned patient was injected with calcium hydroxylapatite (caha), it cannot be excluded with certainty that a merz dermal filler was used since radiesse is on the market in the usa.This case was assessed as reportable to the fda as the events soft filler associated blindness, ischemic stroke, and hemiparesis were deemed to meet the fda serious injury criteria of results in permanent impairment of a body function or permanent damage to a body structure.The events skin necrosis and ophthalmoplegia were deemed to meet the fda serious injury criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as no lot numbers were reported.Citation: sorensen, e.P., & council, m.L.(2019).Update in soft-tissue filler-associated blindness.Dermatologic surgery, 1.Doi: 10.1097/dss.0000000000002108.

Event Description

This case was linked to 3013840437-2019-00022, referring to the same literature article.This is an exemplary case about 1 of 7 patients who received calcium hydroxylapatite and for whom no patient details were available.This literature report from the united states concerns 60 unique cases of filler-associated blindness.The authors conducted a literature search for cases of filler associated blindness published between january 2015 and august 2018.The ovid medline database was searched using the boolean string criteria, described as soft tissue augmentation or filler or injectable plus blindness or ophthalmoplegia or vision or visual impairment or retinal artery occlusion or ophthalmic artery occlusion.The most common type of filler reported was hyaluronidase (ha) (42 patients, 70 percent), followed by autologous fat (7 patients, 11.7 percent), and calcium hydroxyapatite (caha) (7 patients, 11.7 percent).Of the 20 cases that reported data on the injection technique, 6 reported use of a blunt cannula and 14 reported use of a traditional needle.The most common injection locations were the nose (55 percent), glabella (35 percent), and forehead (18.3 percent).These areas presented the greatest at-risk injection sites, likely due to the rich anastomoses between the internal and external carotid vasculature in this area.Patients often noted eye pain (43.3 percent), nausea or vomiting (20 percent), and headache (16.7 percent).Associated signs were ophthalmoplegia (43.3 percent), ptosis (40 percent), skin necrosis (31.7 percent), and acute ischemic stroke (16.7 percent).Of the cases of stroke, 5 (50 percent) were secondary to ha, 2 (20 percent) to autologous fat, 1 (10 percent) to caha, 1 (10 percent) to polylactic acid, and 1 (10 percent) to other.Ischemic strokes occurred in the middle cerebral artery territory and caused permanent hemiparesis.There was no correlation of this risk with the filler type.Most of the affected patients were young, otherwise healthy individuals.There were no cases that involved death.The most commonly reported final diagnosis was ophthalmic artery occlusion (28.3 percent), followed by central retinal artery occlusion (18.3 percent), choroidal emboli (10 percent), and posterior ischemic optic neuropathy (8.3 percent).Regarding treatment, hyaluronidase injection was attempted in most ha cases where management was reported (85.7 percent).The majority of cases (17 out of 24) were treated with hyaluronidase hours to days after the occlusive event using subcutaneous (sq), retrobulbar (rb), and intra-arterial (ophthalmic artery) injection routes.There was 1 successful case where sq injection of 60 units of hyaluronidase to the glabella and nose restored vision when administered 12 hours later.For 6 out of 24 cases treated with hyaluronidase promptly or within minutes, there was vision restoration in 3 cases.In the first case, 1,800 units of hyaluronidase were injected sq and in the supratrochlear foramen minutes after symptom onset.In the second case, prompt injection of 600 units of hyaluronidase was performed into the infraorbital foramen and in a retrobulbar fashion.In the third case, 675 units of hyaluronidase was administered sq and in the supratrochlear and supraorbital notches minutes after symptom onset.In the 3 unsuccessful cases, one used 300 units of hyaluronidase injected rb and sq with no response, one used 150 units of hyaluronidase injected sq with no reported outcome, and one used prompt administration of hyaluronidase but did not report the specific route, dosage, or final outcome.Only 11.1 percent of cases of retrobulbar hyaluronidase injections were successful.Other common treatment modalities included systemic steroids, hyperbaric oxygen, ocular massage, systemic antibiotics, and acetazolamide.Of the 60 cases, 10 reported vision restoration, 28 exhibited permanent vision loss, and 7 did not report treatment outcomes.In the opinion of the authors, blindness remains a devastating potential complication of soft-tissue filler administration.The data suggested that a blunt cannula might reduce, but will not completely eliminate, the risk of filler-associated blindness.The authors noted it is essential for providers to be familiar with the high-risk anatomical areas, early symptoms and signs, and strategies for managing soft-tissue filler blindness.

• 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: 9377723
• MDR Text Key: 168581363
• Report Number: 3013840437-2019-00021
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability