MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	LL-410135
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: analysis of the returned device identified: deformation device, creases fold, yellow particles, cloudy and weight to the spec.Voids in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: exchange from textured to smooth implants due to the patient's concern with the product and capsular contracture.
Event or Problem Description
Healthcare professional reported a left exchange from textured to smooth implants due to the patient's concern with the product and capsular contracture baker grade unknown.Device has been explanted.
Event or Problem Description
Additionally, healthcare professional reported and confirmed baker grade iii.
Additional Manufacturer Narrative
Additional, changed and/or corrected data: a.4., b.5., h.6.Reason for reoperation: capsular contracture, baker grade iii.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9616846
• Report Number: 9617229-2019-23091
• Device Sequence Number: 14137817
• Product Code: FTR
• UDI-Device Identifier: 10888628003170
• UDI-Public: 10888628003170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: LL-410135
• Device Catalogue Number: LL-410135
• Device Lot Number: 3109219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 53