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

Model Number	TCF-485
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iii and bilateral exchange from textured to smooth implants due to the patient¿s concern of the product.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The event of "capsular contracture, baker grade iii" 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 capsular contracture, baker grade iii and bilateral exchange from textured to smooth implants due to the patient¿s concern of the product.Device has been explanted and replaced.
Event or Problem Description
Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ anxiety ¿ product/procedure: unable to observe as it is not related to the device.¿ capsular contracture: unable to observe as it is not related to the device.As per the investigation procedure creases and deformation was completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported right side capsular contracture baker grade iii and bilateral exchange from textured to smooth implants due to the patient¿s concern of the product.Device has been explanted and replaced.

• Brand Name: INSPIRA TEXTURE 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: 15819394
• Report Number: 9617229-2022-19932
• Device Sequence Number: 5329040
• Product Code: FTR
• UDI-Device Identifier: 10888628031142
• UDI-Public: 10888628031142
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2024

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: 05/03/2022
• Device Model Number: TCF-485
• Device Catalogue Number: TCF-485
• Device Lot Number: 3061988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 09/19/2024; 10/03/2024; 10/28/2024
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 09/25/2024; 10/16/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2017
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 51 KG