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

Lot Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Pallor (2468); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Company note: the serious expected event of arterial occlusive disease, the non-serious expected events of pallor, pain, haemorrhage, bruising at implant site and the non-serious unexpected events of livedo reticularis, poor peripheral circulation were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The restylane-l was used off label.The likely root cause include intravascular filler injection leading vascular occlusion and its manifestations or off label use.Potential contributory factor include injection technique.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.

Event Description

Case reference number (b)(4) is a spontaneous literature report identified on (b)(6) 2021 during literature search.This case refers to (b)(6) female patient.Additional information was received on (b)(6) 2021.This case was identified from the literature article ugonabo n, levin mk.Successful treatment of infraorbital occlusion with the high-dose pulsed hyaluronidase protocol: a case report and literature review.J drugs dermatol 2021;20(3):338-339.Http://doi.Org/10.36849/jdd.5489.We present a case of infraorbital arterial occlusion that was swiftly diagnosed and treated with the new high-dose pulse hyaluronidase (hyal) protocol leading to complete resolution of the occlusion and review of the literature of high-dose pulse hyal treatment protocol.A (b)(6) woman presented to a dermatology clinic for soft tissue augmentation of nasolabial folds, cheeks and tear troughs with a hyaluronic acid (ha) based filler, restylane-l.An experienced injector performed an injection in the right tear trough using 1.5-inch 27 g tsk cannula.Aspiration was performed for 5 seconds without any flashback.Transient blanching was noticed in the right infraorbital area by the injector immediately following the injection of 0.2 cc.Capillary refill was tested and noted to be delayed.Shortly after, mottling was noted in the infraorbital region extending to the nasolabial fold.Within 5 minutes, the injector initiated the "high-dosed hyaluronidase protocol" to dissolve the ha filler.Based on the area of involvement, 750 u of hyal were injected into the involved and adjacent areas.Patient was also given 650 mg of aspirin.Reperfusion was repeatedly assessed via capillary refill test, degree of blanching, and symptomatic feedback from the patient.After 30 minutes, blanching had improved significantly, and patient reported decreased pain.However, residual mottling, though decreased from prior, was still noted to be present.Thus, four additional injections of 250 u of hyal were made 30 to 60 minutes apart over the next 120 minutes.60 minutes later, the patient was observed to have continued persistence of good capillary refill.The patient was observed for a total of 4 hours and a total of 1750 u hyal was given while warm compresses were applied for 10-15 minutes each time.The patient was discharged on 325 mg aspirin daily for 7 days.She was seen daily and was noted to have ecchymosis in the area.This gradually resolved leaving no post-procedure scarring, post-inflammatory hyperpigmentation, or skin changes after 2 weeks.The patient's skin during filler injection were consistent with infra-orbital arterial occlusion.Our report of high dose of hyal administration hourly provided remarkable improvement.Vascular compromise due to filler injections, while uncommon will likely increase as the popularity of filer treatments increases.Despite this, there is a paucity of literature on the successful treatment of such vascular compromise.Therefore, this case demonstrates the efficacy of high dose pulsed hyal for the treatment of vascular compromise during injection with ha filler.

• Brand Name: RESTYLANE-L
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 12374865
• MDR Text Key: 273544632
• Report Number: 9710154-2021-00057
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR