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 Problem Necrosis (1971)

Event Type  Injury  

Event Description

This mdr is related to mdr 3013840437-2022-00042, referring to the same patient.This literature report from us concerns a (b)(6) female patient.She was injected with calcium hydroxylapatite, into the right medial cheek (off label use of device).During the calcium hydroxylapatite injection, the patient accidentally received an intravascular injection of filler into the cheek.She felt a severe sudden pain involving the right maxillary region.The treatment was paused, and the patient was allowed to recover, followed by subsequent resumption of the treatment.She was discharged home with instructions for routine use of cold compresses to the face.Within several hours, the patient began experiencing worsening of the cheek pain and new-onset palatal pain, nausea and vomiting, and a visible discoloration of the right cheek and frontonasal region.Approximately 4 hours after the calcium hydroxylapatite injection, the patient presented to the emergency department with a sudden severe right facial pain, presyncope and vomiting.Evaluation by the emergency room physician did not elucidate an underlying diagnosis, and the patient was managed with intravenous morphine, dexamethasone, and ketorolac and discharged home.The following day, the patient noticed worsening skin changes of the right cheek, as well as mucosal discoloration affecting the right hemi-palate.She denied developing any nasal symptoms and noted no visual or neurological deficits.Five days after the injection, the patient experienced livedo reticularis of the right cheek and frontonasal region with central necrotic demarcation of the skin and palatal ulceration following mucosal desquamation.The patient experienced an instance of ischemic skin injury of the infraorbital territory of the face with hemi-palatal mucosal necrosis secondary to vascular occlusion.For 6 weeks, she experienced severe maxillary pain and superficial necrosis of the right cheek and palatal mucosa, which gradually escharified and desquamated, as well as permanent ciliary madarosis of the upper eyelid.The patient was managed conservatively with wound dressings by her primary care physician, and she gradually recovered from the injury over several months.She did not return to her injecting practitioner for a follow-up evaluation due to personal dissatisfaction with the treatment.She presented to the clinic 15 months postinjury with persistent mild erythematous skin discoloration of the right cheek, managed with three sequential 595-nm pulsed dye laser.The patent had monthly treatments with a favorable response and, ultimately, minimally-perceptible scarring.Her palatal mucosal injury healed without permanent sequelae.The outcome of the events hemi-palatal mucosal necrosis and vascular occlusion/ arterial occlusion of the ipsilateral descending palatine artery was reported as resolved.The outcome of the event presyncope was unknown.In the opinion of the authors, acute vascular occlusion secondary to dermal filler injections can result in occult mucosal infarction of the oronasal cavities.Practitioners must be mindful of the possibility of vascular occlusion in individuals demonstrating acute severe pain with tissue discoloration and be prepared to conduct a full examination that includes oral and nasal inspections to rule out mucosal necrosis, as well as aneuro-ophthalmological examination to identify any possible retinal or cerebrovascular injury.

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event hemi-palatal mucosal necrosis (pt: injection site necrosis), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record of radiesse injectable implant could not be reviewed, as the lot number was not reported.Soares, d., blevins, l.(2022).Distal internal maxillary artery occlusion with palatal necrosis following cheek injection with calcium hydroxylapatite, 1-4.Doi: 10.1097/gox.0000000000004164.

Event Description

This mdr is related to mdr 3013840437-2022-00042, referring to the same patient.Follow up information was received on 12-may-2022: the suspect product was recoded from durapatite to radiesse.The patient was injected with radiesse.The outcome of the events remained unchanged.

• 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 rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 13930135
• MDR Text Key: 288041147
• Report Number: 3013840437-2022-00043
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/19/2022
• 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: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female