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U.S. Department of Health and Human Services

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

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MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, embolism/ischemia, was deemed to meet seriousness criteria of necessitated 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 a lot number was not provided.Citation: van loghem j, funt d, pavicic t, et al.Managing intravascular complications following treatment with calcium hydroxylapatite: an expert consensus.J cosmet dermatol.2020;00:1-14.Https://doi.Org/10.1111/jocd.13353.
 
Event Description
This case was linked to mdr 3013840437-2020-00113, referring to the same source from literature.This is a literature case report about managing intravascular complications following treatment with radiesse¿ (also reported as calcium hydroxylapatite, caha).This literature report from (b)(6) concerns a (b)(6)-year-old female patient.She was injected with a total of 0.5 ml of radiesse¿, for correction of nasal bridge, and skin of the columella with non-diluted radiesse¿.She was injected with 0.3 ml into nasal bridge and 0.2 ml into columella using a 22 g 70 mm cannula.There was no skin pathologies, or allergies in the patients medical history.On the same day after the radiesse¿ injection, the patient experienced a slight blanching in the upper lip area.The patient did not report any pain but had received local anesthesia.A reticulate livedo and cyanosis in the upper lip was observed 2 hours after the procedure.The patient was diagnosed with embolism of one of the branches of the upper labial artery.The patient received hyaluronidase injection (1500 units at a standard dilution of 2 ml of 0.9% nacl solution) and sildenafil (100 mg).The following day the patient complained of swelling, reduced sensitivity of the upper lip and blueness in this area.A further dose of sildenafil (100 mg) was prescribed.On the third day after the procedure the patient complained of burning mucosa, increasing swelling, decreased activity of the lip, and numbness of the tip of the nose.Taking into account the negative dynamics, the following treatments were assigned: hyperbaric oxygen therapy (1 procedure lasting 30 min), hyaluronidase (1500 units, injections in the columella and upper lip, 0.5 ml), intravenous infusion of pentoxifylline (400 mg per 250 ml of 0.9% nacl solution for 1 h), dexamethasone intramuscular injection (12 mg), solcoseryl gel on the lip mucosa and sildenafil (100 mg once daily).On the fourth day after the procedure the patients dynamics were more positive.The skin of the upper lip was pale pink, and swelling had decreased.The treatments above were repeated on days 4 and 5 after which the lip had greatly reduced in volume, skin was light pink in color, the mucosa was restored to its pink coloring, and numbness of the lips had decreased.The patient was actively observed for 2 weeks until there was complete resolution of the signs of ischemia.Due to the provided information, the outcome of the event was considered as resolved.In the opinion of the authors, there was a need for an expert consensus on the management of vascular occlusions following inadvertent intra-arterial injection of caha.Avoiding and treating vascular compromise required a detailed understanding of facial anatomy.Early recognition of vascular occlusion and rapid and aggressive treatment were required to avoid irreversible changes.All physicians performing these injections should had a well-stocked supply of recommended medication, treatment options, and devices for impending necrosis or vision loss.The availability of an up-to date, office-based protocol for the prevention and treatment of vascular-related complications was essential for the timely and effective resolution of complications.Follow-up information was received on 13-nov-2020: for this case the country was changed from nl to ru the patients date of birth, height (160 cm) and weight (58 kg) were provided.She was injected supra-periostaly, with a total of 0.5 ml of radiesse¿, into the back of the nose area and columella, for nose correction, on 18-jun-2020.She was injected with 0.3 ml, into one injection point, into the back of the nose and with 0.2 ml into one injection point, into the columella.The procedure was performed under local anaesthesia 0.5 ml of sol.Articaini 4% (as reported).The patients glogau classification was ii and she had a disposition to lymph drainage problems.She had no allergies.The patients medical history included an upper eyelid blepharoplasty under conductive anaesthesia in 2015.Concomitant medication were reported as none.On (b)(6) 2020, 2 hours after the treatment with radiesse¿, the patient experienced livedo (also reported as maramornost skin colour of the upper lip) and an increased pain in the lip.On (b)(6) 2020, reported as on the morning of the next day, erosions appeared on the mucous part of the upper lip.Based on the patient's complaints and visual picture, a diagnosis of columellar artery ischemia was made.On (b)(6) 2019, the patient started with the corrective treatment and received an injection of hyaluronidase 1500 units to the columella area of the upper lip, the tip of the nose, dexamethasone (12 mg intramuscularly), infusion of 250 mg trental sol, nacl 0.9% (500 ml), hyperbaric oxygenation in the pressure chamber 2 procedures with an interval of 2 hours, viagra (100 mg) and nimesil (100 mg 2 times a day for 5 days).On (b)(6) 2018, the treatment and infusion were repeated, injection of hyaluronidase 1500 units to the columella area of the upper lip, the tip of the nose, dexamethasone (8 mg intramuscularly), infusion of 250 mg trental sol.Nacl 0.9% (500 ml), hyperbaric oxygenation in the pressure chamber (2 procedures with an interval of 2 hours).As reported, objectively, there was a positive trend.On (b)(6) 2018, the treatment was continued and the patient received, dexamethasone (4 mg by intramuscular injection), infusion of 250 mg trental sol.Nacl 0.9% (500 ml), hyperbaric oxygenation in the pressure chamber (2 procedures with an interval of 2 hours).There was a positive dynamic, the colour of the skin was restored, erosion on the upper lip mucosa had decreased.A decongestant and anti-inflammatory therapy was performed, from (b)(6) 2018 to (b)(6) 2018.The patient was on loratadine (20 mg 1 tablet per day) and nimesil (100 mg, 1 sachet, 2 times a day, for 7 days).The patient was not hospitalized.The outcome of the event remained unchanged.In the opinion of the reporter, the event was of mild intensity, not life-threatening and not permanent.
 
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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 Key10912627
MDR Text Key218915234
Report Number3013840437-2020-00114
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeRS
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Physician
Type of Report Initial
Report Date 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
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
Date Manufacturer Received11/28/2020
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age34 YR
Patient Weight58
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