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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA Q-MED UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Edema (1820); Embolism (1829); Headache (1880); Unspecified Infection (1930); Ischemia (1942); Nausea (1970); Necrosis (1971); Occlusion (1984); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Loss of Vision (2139); Vomiting (2144); Ulcer (2274); Coma (2417); Loss of consciousness (2418); Respiratory Failure (2484); Ptosis (2620); No Code Available (3191)
Event Type  Death  
Manufacturer Narrative
Pharmacovigilance comment: the serious, unexpected events of cerebral infarction, brain herniation, brain edema, intracranial pressure increased, multiple organ dysfunction syndrome, coma, loss of consciousness and respiratory failure, and the serious, expected events of embolism, blindness unilateral, implant site ischaemia, implant site necrosis and vascular occlusion were considered possibly related to the treatment. Serious criteria include medical interventions, hospitalization, life-threatening condition and death. Cerebral infarction in this case was considered unexpected since cases of possibly related cerebral infarction with a fatal outcome have not been previously reported. The cerebral herniation and multiple organ dysfunction syndrome due to cerebral infarction led to a fatal outcome as malignant cerebral infarction has an 80% mortality in the first week. The non-serious, expected events of periorbital pain, vision blurred, nausea, headache, eyelid ptosis and implant site discolouration, and the non-serious, unexpected events of vomiting, somnolence, mydriasis, pupillary reflex impaired, petechiae, papilloedema and optic nerve ischaemia were considered possibly related to the treatment. The non-serious events of gastric ulcer and lower respiratory tract infection (lrti) were considered unexpected and unrelated to the treatment as gastric ulcer might be stress induced and lrti was likely a nosocomial infection. Potential contributory factors for cerebral infarction include injection technique, intravascular injection of ha filler leading to embolism and vascular occlusion, and preinjection skin edema and ecchymosis that might have prevented the ability to recognize signs of ischemia during the procedure so that urgent treatment could be administered. In addition, nasal augmentation is known to be an area of increased risk for intravascular injection. The case meets the criteria for expedited reporting to the regulatory authorities. Manufacturer comment: lot number was not reported. Capa: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.
 
Event Description
Case reference number (b)(4) is a literature report detected on 21-jan-2020 by the medical affairs department. This case was identified from the literature article yang q, lu b, guo n, li l, ma x, su y et. Al. Fatal cerebral infarction and ophthalmic artery occlusion after nasal augmentation with hyaluronic acid-a case report and review of literature. Aesth plast surg 2020. Https://doi. Org/10. 1007/s00266-019-01589-x. We report a case of massive cerebral infarction and ophthalmic artery occlusion after ha injection for nasal augmentation. The patient died of cerebral herniation and multiple organ dysfunction syndrome. A (b)(6)-year-old asian woman in a coma was transferred to the emergency intensive care unit of our hospital 48 h after she had undergone nasal augmentation by lidocaine-containing ha injection by an unlicensed practitioner. She had reportedly received 2 ml lidocaine-containing ha filler injection via a 25g blunt cannula, with topical 5% lidocaine cream applied for local anesthesia about 40 min before ha injection. No other medication was administered during the procedure. Immediately after the ha injection, the patient had complained of periocular pain and blurred vision in the left eye. She developed nausea, vomiting, and headache, and lost consciousness within 30 min. She was taken to the local hospital 4 h post-injection. According to her relatives, she had no history of coagulopathy or other systemic disease; however, 1 week earlier, she had undergone cosmetic facial autologous fat injection at a private plastic surgery clinic, and had light facial edema and ecchymosis when she presented for the ha injection. On examination at the local hospital, the patient was drowsy, with dilated and nonreactive pupil, blepharoptosis, and absent light reflex in the left eye. The right eye was normal. The skin over the forehead, bilateral periorbital regions, and nasal dorsum showed petechial hemorrhages and purple discoloration. The initial glasgow coma scale (gcs) score was 8, with a positive right babinski sign and a shallow right nasolabial fold. Diffusion-weighted imaging (dwi) performed 24 h after the ha injection revealed hyperacute embolic infarction involving the left frontal and parietal lobes, as well as multifocal infarctions in the left temporal and occipital lobes, and the right frontal and temporal lobes. T2-weighted images revealed high signal intensity of the optic nerve in the left eye, indicating edema and ischemia. Magnetic resonance angiography (mra), however, did not show embolisms of the anterior, middle, and posterior cerebral arteries and the circle of willis and their branches. With a tentative diagnosis of cerebral infarction of undetermined etiology, intravenous mannitol and glucocorticoid were administered to relieve the cerebral edema. However, her condition worsened continuously and was therefore transferred to our hospital. At admission to our hospital, she had gcs score 4. Physical examination showed the features of persistent intracranial hypertension. Her respiratory rate was six breaths per minute and heart rate 37 beats per minute; blood pressure was 75/43 mmhg. The electrocardiogram showed sinus bradycardia, arrhythmia, and nodal escape. Blood examination revealed hypokalemia and relative hypercoagulability. She was mechanically ventilated, and administered medications to maintain blood pressure, reduce neuronal damage, and correct electrolyte imbalance. Emergency decompressive craniectomy was advised, but her guardians refused the procedure. She developed gastric ulceration, pulmonary infection, respiratory failure, and cerebral herniation, and died 6 days after the filler injection. Discussion: our patient was initially suspected to have delayed-onset cerebral infarction induced by autologous fat transplantation (performed a week earlier) and a hypercoagulable status. The patient's skin compromise after the ha filler was mild at the early stage, and whether the etiologic causes for the skin edema and ecchymosis were associated with the earlier autologous fat injection was difficult to identify. Our patient demonstrated no eye or nervous system symptoms after the autologous fat injection, and the only sign was local skin edema and ecchymosis 1 week after the injection. Therefore, cerebral autologous fat infarction was ruled out. The patient mra result did not show evidence of vessel embolism; moreover, the possibility of cerebral infarction due to a hypercoagulable state was ruled out by the following history and clinical presentation. Firstly, the patient had no history of coagulopathy or cardiovascular disease. Secondly, her left eye blindness and intracranial hypertension occurred within 30 min of ha filler injection. Thirdly, the skin ischemia and necrosis increased rapidly with time. With no abnormality in the brain mra results, we speculated that there was probably a rapid distribution of the small ha particles into the capillaries. In the present case, we speculate that the ha particles were either directly injected or forced into the periorbital arteries, and thence into the ophthalmic artery and cerebral arteries via retrograde blood flow. Like the case in this study, the patient did not complain until obvious pain or serious complication occurred. Magnetic resonance imaging indicates cerebral infarction and left ophthalmic artery occlusion. The patient's skin ischemia and necrosis increased with time.
 
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Brand NameUNSPECIFIED HA FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 north freeway
fort worth, TX 76177
8175615353
MDR Report Key9627986
MDR Text Key176275955
Report Number9710154-2020-00010
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P040024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/24/2020 Patient Sequence Number: 1
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