MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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

Patient Problems Inflammation (1932); Skin Discoloration (2074); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "granulomas" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling addresses the reported event(s) as follows: "warnings ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting = 30 days.Refer to the adverse events section for details.Precautions ¿ patients may experience late-onset adverse events with use of dermal fillers, including juvéderm vollure¿ xc.Refer to adverse events section for details.Adverse events per table 1 and table 2: injection site responses by maximum severity and duration after initial treatment occurring in > 5% of treated subjects (n = 123) for possible injection site responses post injection with juvéderm vollure® xc include firmness, swelling, tenderness to touch, lumps/bumps, redness, pain after injection, bruising, itching, and discoloration.Per table 3, injection site responses by severity and duration after repeat treatment with juvéderm vollure® xc occurring in > 5% of treated subjects (n=91) include firmness, swelling, tenderness to touch, redness, lumps/bumps, pain after injection, bruising, itching, and discoloration.Aes after initial/touch-up treatment occurring in = 5% of nlfs included injection site bruising, erythema, pain, discoloration, pruritus, reaction, and facial asymmetry.In general, aes at the nlfs were mild or moderate in severity for both products, with 49.1% (27/55) mild and 29.1% (16/55) moderate for juvéderm vollure¿ xc.Some aes at the nlfs were severe (21.8%, 12/55).The majority of the aes at the nlfs required no action to be taken (94.5%, 52/55) and resolved without sequelae (98.2%, 54/55).Aes at the nlfs after initial/touch-up treatment that required treatment included swelling treated with antihistamines and nsaids, injection site erythema treated with antibiotics, and skin mass that was biopsied and treated with steroids.One subject had mild injection site swelling that occurred after initial/touch-up treatment and was ongoing at the end of the study.This ae did not require treatment.Three adverse events at the juvéderm vollure¿ xc nlfs occurred weeks to months after the injection procedure.These events included mild swelling, moderate skin mass, and severe itching.Swelling was treated with fexofenadine hydrochloride and ibuprofen, the skin mass was treated with triamcinolone, and the itching did not require any treatment.All 3 events resolved without sequelae.All asymmetry corrections (if needed) and repeat treatments were performed with juvéderm vollure¿ xc.In general, aes at the nlfs after asymmetry correction/repeat treatment were similar to those after initial/touch-up treatment.Within the juvéderm vollure¿ xc randomization group, after asymmetry correction/repeat treatment, 20 aes were reported in 10.8% (10/93) of nlfs, with the most common ae being injection site induration (firmness) in 7.5% (7/93) of nlfs.All other aes occurred in < 5% of nlfs and included injection site mass, pain, bruising, erythema, discoloration, and swelling.A majority of the aes after asymmetry correction/repeat treatment in nlfs originally treated with juvéderm vollure¿ xc were mild (20.0%, 4/20) or moderate (45.0%, 9/20) in severity, required no action to be taken (100%, 20/20), and resolved without sequelae (65.0%, 13/20).Some aes after asymmetry correction/repeat treatment were severe (35.0%, 7/20).After asymmetry correction/repeat treatment, seven aes were ongoing at the end of the study and included injection site induration, mass, swelling, bruising, and discoloration.These aes did not require treatment.There were no serious adverse events related to the treatment reported in the study.Postmarket surveillance juvéderm vollure¿ xc has been marketed outside the us since 2011 as juvéderm volift® with lidocaine.The following aes were received from postmarket surveillance on the use of juvéderm vollure¿ xc outside the united states and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.These aes, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, skin nodule, loss/lack of correction, hematoma, allergic reaction, necrosis, infection, flu-like symptoms, paresthesia, migration of device, abscess, drainage, herpes, malaise, headache, and anxiety.In addition, 1 report of blurry vision after injection in the periorbital area, 1 report of blurry vision after injection in an unspecified area, and 1 report of stroke after injections in an unspecified area with multiple dermal fillers were reported.In many cases the symptoms resolved without any treatment.Reported treatments for these events included the use of (in alphabetical order): analgesics, anesthetics, antibiotics, anti-allergy medications, antifungal, antihistamines, anti-inflammatory medications, antiviral, arnica, aspiration, drainage, hyaluronidase, ice, massage, nitrates, oral and topical corticosteroids, and warm compress.Outcomes for these reported adverse events ranged from resolved to ongoing at the time of last contact.".

Event Description

Company representative reported on behalf of healthcare professional that an unknown time after injection in an unspecified injection site with juvéderm vollure¿ xc, the patient developed granulomas in an unspecified location.The patient was referred to an infectious diseases doctor by a different physician.Steroids were given as treatment and the patient reported that more granulomas appeared an unknown amount of time later.No biopsy results were reported.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The events of skin changes and lesions are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Further follow-up with the healthcare professional revealed that the patient was injected in the ¿nlf and marionette bilateral¿ with 1 syringe of juvéderm vollure¿ xc and developed granulomas at and around the injection site 8 days later.Treatment with a medrol dose pack was given approximately 3 weeks after symptom onset.Steroid was given as an injection one week later and treatment with hylenex was injected one week after the steroids.Symptoms are ongoing.Healthcare professional reported the patient¿s ¿skin changes over areas of granulomas including areas not injected with steroid¿ and patient ¿continues to develop lesions in and around areas of injection." some are in area juvéderm vollure¿ xc was injected and ¿others are 1 cm away.¿ no biopsy was performed to confirm the granulomas.An ¿aspiration left cheek¿ was performed on the same day as the medrol dose pack treatment.Results showed ¿no growth.Moderate wbc.¿ patient had an ¿infectious disease consultation¿ at which healthcare professional ¿felt granulomas reaction.¿.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7083150
• MDR Text Key: 93735686
• Report Number: 3005113652-2017-01570
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR