MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA3; HYALURONIC ACID DERMAL FILLER GEL

Model Number N/A

Device Problem Migration (4003)

Patient Problems Death (1802); Thrombosis/Thrombus (4440)

Event Date 10/15/2020

Event Type  Death  

Manufacturer Narrative

Following a literature review, teoxane is unaware of any prior reports of the rare and unexpected serious event of thrombosis of the sagittal, transverse, and sigmoid sinuses following injection of hyaluronic acid in the lips.A causality assessment is not possible at this time based on the rarity of the event and the limited information available.Potential contributory factors for thrombosis of the sagittal, transverse and sigmoid sinus may include use of oral contraceptives and the passage of up to 48 hours without medical intervention.Teoxane's batch data review showed that the batch was released in accordance with the product specifications.As far as the company is aware, there are no other reports or complaints associated with this batch.In addition to review of batch records, the company's investigation of this event has included contacting the initial reporters of the event.The investigation is ongoing, and teoxane will provide an updated report if additional information becomes available.

Event Description

This case occurred in europe.On (b)(6) 2021, a case was reported to teoxane indirectly.The case relates to the death (due to thrombosis) of a (b)(6) patient (with a medical history of rhinoplasty and breast enhancement) that occurred a few days after a dermal filler injection in the lips using a "tenting technique" on (b)(6) 2020.It was reported that the patient tested negative for covid-19, had no history of autoimmune disease, and was taking oral contraceptives.After the injection, pictures and a video of the results were reportedly taken by the injector without any immediate signs of complications.According to the injector, who spoke with the patient about 30 minutes after the procedure, he did not notice any particular reactions (such as pain, signs of vascular disorder, or necrosis) during this time period.According to the injector, the day after the injection, the patient reported pain at the injection site and headaches to her family and was later hospitalized in a coma after remaining alone for two days.The hospital report received on (b)(6) 2021 stated that the patient underwent percutaneous coronary intervention (pci) emergency procedures followed by a craniectomy.On (b)(6) 2020, the patient was declared brain dead due to a non-responsive state and died within a timeframe that is not known at this stage.Following an autopsy, the hospitalized patient was reportedly diagnosed with extremely rare thrombosis of the middle and posterior thirds of the superior sagittal sinus and complete thrombosis of the bilateral transverse and sigmoid sinuses.The autopsy report has not been made available to teoxane.According to the hospital report, the analysis suggests the presence (in the thrombus) of residual hyaluronic acid particles reportedly similar to those found in the lips (shown by the presence of hyaluronic acid during light microscopy and detection of nanoparticles during electron microscopy).Due to lack of information, it is not possible to determine the origin or form of the hyaluronic acid observed in the post-mortem thrombus and the timing of its possible dislocation to the thrombus.No other information regarding the event is available at the time of this report.

Event Description

This case occurred in belgium.On february (b)(6) 2021, a case was reported to teoxane indirectly.The case relates to the death (due to thrombosis) of a 23-year-old patient (with a medical history of rhinoplasty and breast enhancement) that occurred a few days after a dermal filler injection in the lips using a "tenting technique" on (b)(6) 2020.It was reported that the patient tested negative for covid-19, had no history of autoimmune disease, and was taking oral contraceptives.After the injection, pictures and a video of the results were reportedly taken by the injector without any immediate signs of complications.According to the injector, who spoke with the patient about 30 minutes after the procedure, he did not notice any particular reactions (such as pain, signs of vascular disorder or necrosis) during this time period.According to the injector, the day after the injection, the patient reported pain at the injection site and headaches to her family and after remaining alone for two days, was hospitalized in a coma.The hospital report received on (b)(6) 2021 stated that the patient underwent pci emergency procedures followed by a craniectomy.On (b)(6) 2020, the patient was declared brain dead due to a non-responsive state and died within a timeframe that is not known at this stage.Following an autopsy, the hospitalized patient was reportedly diagnosed with extremely rare thrombosis of the middle and posterior thirds of the superior sagittal sinus and complete thrombosis of the bilateral transverse and sigmoid sinuses.The autopsy report has not been made available to teoxane.According to the hospital report, the analysis suggests the presence (in the thrombus) of residual hyaluronic acid particles reportedly similar to those found in the lips (shown by the presence of hyaluronic acid during light microscopy and detection of nanoparticles during electron microscopy).Due to lack of information, it is not possible to determine the nature or form of the hyaluronic acid observed in the post-mortem thrombus and the timing of its possible dislocation to the thrombus.No other information regarding the event is available at the time of this report.Following the prior submission, no additional information has been added in this section b5.Following updates have been made: section h6 : investigation conclusions code was updated from : 11 to 4315.Section h10 has been revised.

Manufacturer Narrative

Following the prior submission, the company consulted an independent neuro-radiologist expert, who reviewed the case and provided an analysis.The independent expert confirmed the company's literature search and the uncommonness of the case.He found it noteworthy that, unlike the rare cases reported in the literature, the patient in this case did not report neurological symptoms near in time to the injection.The expert neuro-radiologist could not rule out a causal connection, but he found certain evidence to be discrepant with such a relationship.In addition to the lack of concomitant symptoms, the neuro-radiologist remarked that the small quantity of material injected and the diameters of the patient's venous structures did not appear to be consistent with a causal role for the injection.As a possible alternative explanation, the neuro-radiologist hypothesized that hyaluronic acid from the injection could have fixated on a pre-existing thrombus, as opposed to having played a causal role in the formation of the thrombus.Due to the remaining uncertainty following medical expert review, the company concludes that the cause of the patient's thrombosis cannot be determined.Teoxane's batch data review showed that the batch was released in accordance with the product specifications and had not been released in the us.The risk associated with unintended intravascular injection is already covered in both the ifu and patient brochure.

• Brand Name: TEOSYAL RHA3
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 11422383
• MDR Text Key: 234968774
• Report Number: 3005975625-2021-00029
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: TP27L-194915C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 23 YR