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

Lot Number 19460

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

Patient Problems Obstruction/Occlusion (2422); Pallor (2468); Peripheral Nervous Injury (4414); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2022

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 17-mar-2022 by a registered nurse which refers to a female patient of an unknown age.Additional information was received on 18-mar-2022 and 21-mar-2022 from same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On 14-mar-2022, the patient received treatment with 0.25 ml restylane kysse, 0.1 ml to top and bottom lip, 0.15 ml to the corners of mouth and marionette line (unknown lot number, injection technique and needle type).The restylane kysse was injected to marionette line (off label use of device).According to hcp, post injection everything looked good.On 15-mar-2022, the patient presented to hcp office with an area of no capillary refill/decreased capillary refill (poor peripheral circulation), pallor (implant site pallor) and vascular occlusion (vascular occlusion) of the lip.The patient was treated with tylenol [paracetamol], hyperbaric chamber, warm compresses and hylenex [vorhyaluronidase alfa].The patient was being treated at the hcp office everyday since 15-mar-2022 as she was presenting each day with a different area of occlusion and the occlusion was spreading.The last dose of hylenex was administered on 18-mar-2022.On 18-mar-2022, the patient was seen by a plastic surgeon, who stated everything looked ok.As per reporting hcp, the patient was being followed up non-stop every day and even on 21-mar-2022.Outcome at the time of the report: vascular occlusion was recovering/resolving.No capillary refill/decreased capillary refill was recovering/resolving.Pallor was recovering/resolving.Restylane kysse was injected to marionette line was recovered/resolved.

Manufacturer Narrative

Company comment: the serious event of vascular occlusion and the non-serious events of pallor at implant site and poor peripheral circulation were considered 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 and its manifestations.Potential contributory factor include injection technique.The restylane kysse was used off label.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.Lot number was not reported and the product could not be verified.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.

Manufacturer Narrative

Company comment: the serious event of vascular occlusion and the non-serious events of pallor at implant site 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 and its manifestations.Potential contributory factor include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane kysse-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.Capa: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4)is a spontaneous report sent on 17-mar-2022 by a registered nurse, which refers to a 49 year old female patient.Additional information was received on 18-mar-2022 and 21-mar-2022 from same reporter.The patient had no known medical history or allergies.Concomitant medications included spironolactone [spironolactone] and adderall [adderall] as needed.The patient had previously received treatments with juvederm ultra plus xc to lips and radiesse to marionette area on (b)(6) 2016 and vollure xc to lips and marionette area on (b)(6) 2020 by another provider.The patient had no dental procedures in the last 6 to 12 months or any illness in the month prior to the treatment.On (b)(6) 2021, the patient had received first dose of moderna covid-19 vaccine.On (b)(6) 2021, the patient had received second dose of moderna covid-19 vaccine.On(b)(6) 2021, the patient had received booster dose of moderna covid-19 vaccine.On (b)(6) 2022, the patient received treatment with total 0.25 ml restylane kysse (lot 19460), 0.05 ml each to top and bottom lip and 0.15 ml to oral commissures using 30g needle with retrograde linear and fan technique for volume loss.The product was injected slowly and aspiration with each injection superficial/sub-mucosal to lips and sub-dermally to oral commissures.According to hcp, post injection the patient was well.On (b)(6) 2022, the patient presented to hcp office with an area of no capillary refill/decreased/delayed capillary refill (poor peripheral circulation), pallor (implant site pallor) and vascular occlusion (vascular occlusion).There were multiple spots of vascular occlusion along the top and bottom lip.The patient was treated with tylenol [paracetamol], hyperbaric chamber, warm compresses and hylenex [vorhyaluronidase alfa].The patient was being treated at the hcp office everyday since (b)(6) 2022 as she was presenting each day with a different area of occlusion and the occlusion was spreading.The last dose of hylenex was administered on (b)(6) 2022.The hcp believed that the vascular occlusion might have traveled along the sla and right ila.On (b)(6) 2022, the patient was seen by a plastic surgeon, who stated everything looked ok.As per reporting hcp, the patient was being followed up non-stop every day till (b)(6) 2022.On (b)(6) 2022, the patient would be followed up by hcp.Outcome at the time of the report: vascular occlusion was recovered/resolved.No capillary refill/decreased/delayed capillary refill was recovered/resolved.Pallor was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 01-apr-2022 from the same reporter: verbatim of event (poor peripheral circulation) updated.Event (off label use of device in marionette lines) deleted.Patient demographics, past filler treatments, concomitant medications, covid-19 vaccination details, suspect device implant location, lot number, injection technique, needle type, outcome and severity of the events were updated.

• Brand Name: RESTYLANE KYSSE
• 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: 14017569
• MDR Text Key: 292384116
• Report Number: 1000118068-2022-00009
• 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,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Lot Number: 19460
• 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: 04/25/2022
• Distributor Facility Aware Date: 04/01/2022
• Event Location: Other
• Date Report to Manufacturer: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDERALL; SPIRONOLACTONE
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female