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

Catalog Number	MX-410620
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: capsular contracture baker grade unknown, anxiety-product/procedure.
Event or Problem Description
Patient reported left side capsular contracture baker grade unknown and replacement from textured to smooth due to the patient concern of the implant.Device remains implanted.
Event or Problem Description
It has been determined that the event associate with this complaint did not occur.This record is no longer reportable to fda and will be un-reported.
Additional Manufacturer Narrative
Lab analysis: the device is related to the reported event capsular contracture and anxiety ¿ product/procedure of implant received on (b)(6) 2024, with lot number 2982222.Based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe as it is not related to the device.Anxiety ¿ product/procedure: unable to observe as it is not related to the device.A review of the device history record has been completed.No deviations or non-conformances noted.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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: capsular contracture grade iii.
Event or Problem Description
Patient reported left side capsular contracture, baker grade unknown and replacement from textured to smooth due to the patient concern of the implant.Later, healthcare professional reported capsular contracture, grade ii.Healthcare professional later reported "capsular contracture, baker grade iii.Device has been explanted and replaced.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 17437844
• Report Number: 9617229-2023-12302
• Device Sequence Number: 8942510
• Product Code: FTR
• UDI-Device Identifier: 10888628003781
• UDI-Public: 10888628003781
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 10/02/2021
• Device Catalogue Number: MX-410620
• Device Lot Number: 2982222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 02/06/2024; 02/19/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 02/09/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 69 KG