MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-203
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side rupture.Device has been explanted.
Additional Manufacturer Narrative
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: rupture.
Event or Problem Description
Patient reported right side rupture.Healthcare professional reported right side rupture confirmed via mri.Later, physician reported capsular contracture, baker grade iii.Device has been explanted.
Additional Manufacturer Narrative
Visual analysis: visual analysis of the photographs identified: ¿ rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.¿ capsular contracture: unable to observe as it is a medical event that is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.
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.Reason for reoperation: capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported right side rupture confirmed via mri.Later, physician reported capsular contracture, baker grade iii.
Event or Problem Description
Patient reported, right side rupture.Healthcare professional reported, right side rupture.Confirmed via mri.Later, physician reported, capsular contracture, baker grade iii.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: 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.Rupture: observed broken assessed as surgical damage.Additional observations: no other observation observed.No further actions are required since no manufacturing issue is observed.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.
Event or Problem Description
Patient reported right side rupture.Healthcare professional reported right side rupture confirmed via mri.Later, physician reported capsular contracture, baker grade iii.Device has been explanted.

• Brand Name: STYLE 115 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: 17903792
• Report Number: 9617229-2023-16382
• Device Sequence Number: 7823155
• Product Code: FTR
• UDI-Device Identifier: 10888628002333
• UDI-Public: 10888628002333
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 09/21/2022
• Device Catalogue Number: 115-203
• Device Lot Number: 3119651
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 11/02/2023; 05/29/2024; 06/15/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/02/2023; 11/25/2023; 05/31/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2017
• 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 Sex: Female