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 Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event vascular compromise (pt: vascular compression), 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.Kern, j., kollipara, r., hoss, e., boen, m., wu, d., groff, w., goldman, m.(2022).Serious adverse events with injectable fillers: retrospective analysis of 7,659 patient outcomes, dermatologic surgery, 1-5.Doi: http://dx.Doi.Org/10.1097/dss.0000000000003409.

Event Description

This case was linked to lssmv case number (b)(6) referring to the same literature article.This is a literature report from a retrospective study aimed to analyze injectable filler treatments spanning 11 years at a high-volume cosmetic dermatology practice to determine the incidence, management, and final outcome of these filler-related adverse events.This literature report from united states of america concerns a 34-year-old male patient.He was injected with a total of 1.5 ml of calcium hydroxyapatite, into the right medial cheek (off label use of device).The patient was injected in a single session with no more than 0.5 ml injected, into a single site.The patient had a history of nonabsorbable filler comprised polymethylmethacrylate microspheres in the treatment area, 3 years before.After the calcium hydroxyapatite injection, the patient experienced vascular compromise and secondary cutaneous necrosis.The cutaneous necrosis was on the cheek (site of prior polymethylmethacrylate microspheres injection).The events were quickly identified and managed appropriately.Initial treatment consisted of aspirin, pentoxifylline, nitroglycerin paste, 8 minutes of red light therapy to decrease inflammation, and prophylactic clarithromycin and valacyclovir.After noting minimal improvement, the patient was then treated with 14 dives of hyperbaric oxygen therapy.The patient was treated with hyperbaric oxygen, topical wound care with silicone dressings, and fractionated laser resurfacing and achieved complete resolution of epidermal scaring.The outcome of the events was reported as resolved.In the opinion of the authors, occlusion possibly occurred because of direct compromise of the intravascular space, compression of the vessel because of the surrounding edema and mass effect, or embolization of the filler to a distant site.Depending on the anatomic allocation and percentage of occlusion, sequelae ranged from local tissue necrosis to blindness and even stroke.Even with prompt management, vascular complications had the possibility to be irreversible.In addition, it was important that patients divulged their cosmetic treatment history before receiving filler because complications arose because of underlying fibrosis, anatomic variations, or other skin changes resulting from previous procedures.

Event Description

Follow up information was received on 11-apr-2022: the suspect product was recoded from durapatite to radiesse.The patient was injected with radiesse.The outcome of the event 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: 13803617
• MDR Text Key: 291234741
• Report Number: 3013840437-2022-00040
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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: 03/08/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/13/2022
• 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: 34 YR
• Patient Sex: Male