MAUDE Adverse Event Report: Q-MED RESTYLANE CONTOUR; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 19135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Necrosis (1971); Obstruction/Occlusion (2422); Pallor (2468); Unspecified Vascular Problem (4441); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/29/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious events of necrosis and ischaemia at implant site and vascular occlusion and the non-serious events of pain and pallor at implant site, eschar and poor peripheral circulation were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion causing ischemic manifestations and necrosis at implant site.Potential contributory factor include injection technique.Restylane contour was used off label (pyriform aperture).The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 01-feb-2022 by a registered nurse, which refers to a (b)(6) female patient.Additional information was received on 01-feb-2022 from a physician and on 08-feb-2022 and 09-feb-2022 from the same nurse.The patient's medical history included methamphetamine abuse and past smoking use and she had been sober for 10 years.The patient had no known allergies.No information about concomitant medications has been provided.The patient had not received any injections of cosmetic filler or toxins in the past.On an unknown date, the patient had received first dose of an unspecified covid-19 vaccine and second dose in (b)(6) 2021.In 2020 (2 years ago), the patient had full upper and lower dental implants.She had all teeth removed and a lot of metal screws placed into her mouth.In (b)(6) 2022 (4 weeks ago), the patient was tested positive for omicron virus.On (b)(6) 2022, the patient received treatment with 1 ml restylane contour (lot 19135), 0.5 ml to each side of the mid cheek v-shaped deformity and piriform aperture (unknown needle type and injection technique).When hcp did a block, her needle was hitting metal.There was no blanching noticed during the injection.The restylane contour was injected to pyriform aperture (off label use of device).On (b)(6) 2022 in the middle of the night, the patient woke up with throbbing pain (implant site pain) in face and could not sleep.On (b)(6) 2022 in the early morning, the patient called hcp to inform about throbbing pain and also that she noticed blanching (implant site pallor), necrosis (implant site necrosis) on the left medial cheek area and cap refill was delayed (poor peripheral circulation).The physician instructed patient to meet at the office.This was her first case of vascular occlusion (vascular occlusion).On (b)(6) 2022, the patient visited the hcp office.The patient was treated with 2 aspirin [acetylsalicylic acid] and then placed on clindamycin [clindamycin] 300 mg three times a day, valtrex [valaciclovir hydrochloride] 2 g for two days and then 1 g subsequent days (9 pills in total) and viagra [sildenafil citrate] 25 mg every six hours (8 tablets total).The hcp infiltrated area with injections of vitrase [hyaluronidase] 2.5 vials and hylenex [vorhyaluronidase alf] 3 vials with 50% lidocaine [lidocaine] into the area that looked ischaemic (implant site ischaemia) and worked it into the tissue.In addition, 4 more vials of hylenex was used 2 cm below the inner canthal area of the eye, close to the alar crease as the patient was still complaining of pain.An area of whiteness was noted in this area on exam with a nasal scope.A 30g 1 inch needle was used for injections in this area with multiple deposits of hyaluronidase and the throbbing pain went away.The physician felt that the patient seemed to be doing pretty well.The patient was treated at the office for 3 to 4 hours.Delorenzi protocol was used with injecting hyaluronidase, wait and observe the patient for an hour and repeat.On (b)(6) 2022, the physician saw the patient back in office, who reported that the patient did not look good and was experiencing pain to touch in the left cheek.The patient was then treated with pro-nox nitrous oxide [nitric oxide] and percutaneous infraorbital vitrase and hylenex injections (each 3 vials in total).The patient was moved out to a hyperbaric chamber.Same day when the patient returned, the physician had attached a device called e-o2, which was a patch connected to a portable transducer box worn on the shoulder which gives 100% ox to drying tissue.The e-o2 company recommended to wear it for two days.On (b)(6) 2022, the patient returned to the hcp office.The patient had some eschar (eschar) debrided and underneath it was pink.The patient had no pain.Outcome at the time of the report: necrosis was not recovered/not resolved/ongoing.Vascular occlusion was not recovered/not resolved/ongoing.Ischemic was not recovered/not resolved/ongoing.Throbbing pain was recovered/resolved.Cap refill was delayed was not recovered/not resolved/ongoing.Blanching was not recovered/not resolved/ongoing.Eschar was unknown.Restylane contour was injected to piriform aperture was recovered/resolved.

• Brand Name: RESTYLANE CONTOUR
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 13624897
• MDR Text Key: 290939962
• Report Number: 1000118068-2022-00005
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Lot Number: 19135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2022
• Distributor Facility Aware Date: 02/01/2022
• Event Location: Other
• Date Report to Manufacturer: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female