MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLIFT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reports using a cannula to inject a juvéderm® volift ¿ with lidocaine in the bilateral nasogenian groove/nasolabial fold region.Positive aspiration denied.Hcp injected product to the right nasogenian groove and noticed a color change on the right side when moving to the left side.Hcp had doubts as to whether it would be an arterial obstruction.The procedure continued, applying juvéderm® volift¿ with lidocaine to the lips.When the application on the lips was finished, livedo in the supralabial, perinasal and right malar regions was already quite evident.The patient denied pain at any time.Initially, 1 ampoule of reductonidase (1500 rtu) was applied.In the following hours, hcp injected 2 more ampoules of 2000utr from biomethyl, without significant improvement.Patient received aas 500mg and prednisone 40mg.Patient was evaluated by a radiologist, who has no experience with fillers and did not identify arterial or venous obstruction on ultrasound examination.Hcp also requested an evaluation by a vascular physician, who indicated associating vasogard (cilostazol).Two days post injection, physician continues to perform hyaluronidase applications and the patient continues with asa, prednisone, massage, warm compresses and daily hyperbaric chamber sessions.Another specialist is consulting on the case for treatment.One week after the obstruction occurred, injector noted that patient's issue is evolving well.

• Brand Name: VOLIFT (VOLUME UNKNOWN)
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10880005
• MDR Text Key: 217701942
• Report Number: 3005113652-2020-00720
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLIFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR