MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE LYFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Erythema (1840); Ischemia (1942); Necrosis (1971); Pain (1994); Peripheral Vascular Disease (2002); Skin Discoloration (2074)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of necrosis at implant site was considered possibly related to the treatment.Serious criteria include the need for urgent medical intervention with hylenex.The non-serious expected events of pain, discolouration at implant site and unexpected event of poor peripheral circulation were considered possibly related to the treatment.Potential contributory factor include intravascular filler injection leading to occlusion of blood vessels supplying the nasolabial folds and tip of nose area, with subsequent manifestations of ischaemia.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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.Manufacture narrative: lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by a physician which refers to a female patient of an unknown age.Additional information was received on 18-jun-2020 from same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with 0.2 to 0.4 ml restylane lyft with lidocaine to nasalobial folds (0.1 to 0.2 ml on each side) (unknown lot number, injection technique and needle type).1 day later, on (b)(6) 2020, the patient experienced (implant site pain) to tip of nose, some discoloration(implant site discolouration) and delayed capillary refill(poor peripheral circulation) from right nasolabial fold to the tip of nose.The hcp treated patient with 200 units of hylenex [hyaluronidase].The patient returned later in the afternoon for another 200 units of hylenex.2 days after the injection, on (b)(6) 2020, the patient experienced possible necrosis(implant site necrosis) to the tip of nose and patient was on her way to office for possible treatment with hylenex.Outcome at the time of the report: possible necrosis was not recovered/not resolved.Pain to tip of nose was not recovered/not resolved.Discoloration was not recovered/not resolved.Delayed capillary refill was not recovered/not resolved.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 17-jun-2020 by a physician which refers to a female patient of an unknown age.Additional information was received on 18-jun-2020 from same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with 0.2 to 0.4 ml restylane lyft with lidocaine to nasolabial folds (0.1 to 0.2 ml on each side) (unknown lot number, injection technique and needle type).One day later, on (b)(6) 2020, the patient experienced pain (implant site pain) to tip of nose, and returned to the office in the morning.The hcp reported that the patient had impending/possible necrosis (implant site necrosis) with pain, erythema (implant site erythema), slight delayed capillary refill (poor peripheral circulation) and some discoloration (implant site discolouration) from right nasolabial fold to the tip of nose.The hcp immediately flushed the area, treated with 200 units of hylenex [hyaluronidase], applied nitro paste [glyceryl trinitrate] and massaged and compressed heat to the area, and then asked the patient to return later in the day on (b)(6) 2020.The hcp treated her again with 200 units of hylanex and repeated the massage and compressed heat to area.On (b)(6) 2020, the patient then sent pictures and the doctor reported ischemia (implant site ischaemia) on the tip of the patient's nose.On (b)(6) 2020, the hcp reported, that the patient was on her way to her office for treatment with additional hylanex for possible necrosis on the tip of her nose.The hcp reported the events had resolved.Outcome at the time of the report: impending/possible necrosis was recovered/resolved.Ischemia was recovered/resolved.Pain was recovered/resolved.Discoloration was recovered/resolved.Delayed capillary refill was recovered/resolved.Erythema was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 30-jun-2020 from the same reporter.Events (ischemia and erythema at implant site) added.Suspect device implant date, event onset date, outcome and corrective treatment details were updated.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected adverse events of implant site necrosis and implant site ischaemia were considered possibly related to the administration of restylane lyft with lidocaine.Seriousness criteria included urgent medical intervention, including treatment with hyaluronidase.The non-serious expected adverse events of implant site pain, implant site erythema, implant site discolouration, as well as the unexpected adverse event of poor peripheral circulation (reported as delayed capillary refill, understood to have also been observed at implant site) were also considered possibly related to the administration of restylane lyft with lidocaine.No information was provided by the reporter with regard to this patient's age or medical history.Potential contributory factors may include an erroneous injection technique (e.G.Intravascular injection of filler), eventually leading to occlusion of blood vessels supplying the nasolabial folds and tip of nose area, with subsequent manifestations of local ischaemia.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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.Manufacture narrative: lot number was not reported.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10218202
• MDR Text Key: 197570067
• Report Number: 9710154-2020-00055
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention