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

Lot Number 18393

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

Patient Problems Ecchymosis (1818); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of vascular occlusion was considered expected and possibly related to the treatment.Serious criteria include the need for medical intervention with multiple hyaluronidase treatments to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: 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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-mar-2021 by another health professional which refers to an adult patient of unknown gender.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date, the patient received treatment with restylane kysse (unknown amount, lot number, injection technique and needle type) to unknown location.Unknown time later, on an unknown date, the patient experienced vascular occlusion.On an unknown date, the patient was treated with multiple flushes of hylenex [hyaluronidase].Outcome at the time of the report: vascular occlusion was unknown.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-mar-2021 by an other health professional which refers to an 42-year-old female patient.The patient had no known medical history or allergies.No information about concomitant medications has been provided.The patient had previously received treatment with restylane kysse on (b)(6) 2020 to lips.The patient had no vaccines, any dental procedures in last 6 to 12 months or any illness in the month prior to the treatment.On an unknown date, the patient received treatment 1 ml restylane kysse (lot 18393), 0.5 ml to each lip using 25g 1.5 cannula and 30g 0.5 needle with unknown injection technique.Unknown time later, on (b)(6) 2021, the patient experienced vascular occlusion(vascular occlusion) on upper vermillion-lip.The patient initially presented with mottling(livedo reticularis), fainting above right side vermillion.Post warm compression, mottling was resolving.It was slight pale(implant site pallor) and dusky coloration(implant site discolouration).Assessment performed after 10 minutes, confirmed initial mottling began dissolving.The patient was treated with hylenex [hyaluronidase] 1200u total from (b)(6) 2021, aspirin [acetylsalicylic acid] 85 mg once daily for 5 days and cialis [tadalafil] 1 tablet for 2 days from (b)(6) 2021.The patient experienced bruising(implant site bruising) and swelling(implant site swelling) after hylenex treatment.Dusky coloration was still present but perfusion confirmed.The follow up plan was discussed for 2 hours post treatment.The follow up and treatment plan was continued for 4 days with increasing resolution.On (b)(6) 2021, the vascular occlusion was resolved and perfusion present.Outcome at the time of the report: vascular occlusion was recovered/resolved.Mottling was recovered/resolved.Dusky coloration was recovered/resolved.Slight pale was recovered/resolved.Swelling was recovered/resolved.Bruising was recovered/resolved.Tracking list: v.0 initial; v.1 fu received on 19-mar-2021 from another registered nurse: events (mottling, dusky coloration, slight pale, swelling, bruising) added.Patient demographics, past filler, suspect device volume, needle type, location, lot number, expiry date, onset date, location, severity, outcome of event vascular occlusion and corrective treatment details were updated.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of vascular occlusion and the non-serious expected events of pallor, discolouration, bruising and swelling at implant site and livedo reticularis 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 for swelling and bruising at implant site include hylenex treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: 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.

• Brand Name: RESTYLANE KYSSE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11578490
• MDR Text Key: 259125972
• Report Number: 1000118068-2021-00010
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Lot Number: 18393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Distributor Facility Aware Date: 03/19/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR