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

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

Patient Problems Embolism (1829); Erythema (1840); Ischemia (1942); Pain (1994); Skin Discoloration (2074); Pallor (2468); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: lot number was not reported.Capa comment: 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.Pharmacovigilance comment: the serious expected events of embolism arterial, vascular compression and ischaemia at implant site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage or disability.The non-serious expected events of pain, pallor, discolouration and erythema at implant site were considered possibly related to the treatment.Potential etiologies include injecting filler into the blood vessel, leading to emboli and vascular occlusion, and vascular compression from postprocedural swelling and the implant.Potential contributory factors include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a literature report sent on 18-dec-2019 by an other health professional which refers to a (b)(6)-year-old female patient.This case was identified from the literature article xue-li li, yun-fei li, hua-juan wu, li-na d, chun-yang z, hong c.Early signal and prevention analysis of vascular embolism caused by hyaluronic acid injection of nasolabial fold.Clinical data: a female, (b)(6) years old, received linear superficial injection of hyaluronic acid restylane (q-medab, sweden) 0.4ml to the right nasolabial fold using a sharp needle, and then complained of transient pain when the needle was withdrawn 1 cm away from the level parallel to the right lip, 5 min after which there were pallor graniphyric changes in the right upper lip skin site.The injection was discontinued immediately, and corresponding measures were given.Analysis of anatomical mechanism and etiology for vascular embolism: the case 2 experienced erythema on skin of upper lip, it was considered that there was vascular embolism or compression in the region from facial artery to upper lip arterial branches which lead to the ischaemic skin manifestations in the upper lip arterial blood supply region.Emergent countermeasures for embolism: as to the patient with vascular embolism symptoms at nasolabial fold injection site, the injection was discontinued immediately when they experienced vascular embolism symptoms including whitening and lilac color changes on skin in hyaluronic acid injection related region.Comprehensive treatment was applied, and rescue measures were taken.The specific measures included: injecting hyaluronidase: it often contains 1500 u hyaluronidase and can be diluted in normal saline 1 ml to prepare 1500 u/ml solution.Collect 0.1 ml of the solution (containing hyaluronidase 150 u) can be dissolved by a ratio of 1:1.Inject hyaluronidase to the corresponding sites, commonly 0.05-0.1 ml at each site will make it effective.The injection velocity is better slow and the layer is better deeper, and moderate massage is beneficial to the drug diffusion.As to case 1, the injection site was nasolabial fold, thus hyaluronidase multi-point injection (150-600 u at each site, with total volume up to 1500 u) should be given immediately at injection site and local vascular embolism sites.Local hot compress: warm gauzes (at 30[?]-50[?]) should be externally applied immediately at injection sites and vascular embolism sites so as to dilate local vessels, increase local skin blood supply and reduce tissue ischemia and anoxia.Using vasodilators: take sublingual administration of nitroglycerin tablets (0.5 mg); low molecular dextran 500ml ivgtt, for consecutive 1 week.Oxygen therapy: give oxygen aspiration at 3-5 l/min immediately, followed by hyperbaric oxygen therapy every day in the subsequent 2 weeks, so as to promote the local oxygen content in ischemic tissues, reduce tissue ischemic re-perfusion injury and improve local microcirculation and nutritional state, so as to accelerate tissue recovery and the dissolution and absorption of necrotic tissues.Preventing infection: externally apply 0.1% benzalkonium chloride solution and mupirocin ointment; give acyclovir tablets 0.4mg tid for preventive treatment for patients with past history of herpes simplex.Preventing pigmentation: externally apply mucopolysaccharide polysulfate cream on local skin for consecutive 2 weeks since the mucopolysaccharide polysulfate can prevent the superficial thrombosis, promote tissue absorption, prevent the development of local inflammation, accelerate the absorption of hematoma, and promote the regeneration of normal connective tissues.Conclusion: both cases received above active treatments after the occurrence of embolism.As to case 2, the skin in vascular embolism region recovered to normal immediately after above treatment without pigmentation, breakdown or scar remained.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 9555522
• MDR Text Key: 189470745
• Report Number: 9710154-2020-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 42 YR