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

Catalog Number	TSM-445
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued h.6: f2201.A review of the device history record has been completed.No deviations or non-conformances noted.The reported events of "capsular contracture, baker grade iv" and "seroma-late" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 iv and seroma-late.
Event or Problem Description
Healthcare professional reported a right side implant exchange from textured to smooth due to the concerns of the product.Healthcare professional later reported a capsular contracture, baker grade iv, ¿capsule and consists of white plastic material grossly resembling a breast capsule", "benign lymphohistiocytic inflammation", "right breast seroma fluid from intracapsular layer and consists of yellow fluid¿ and ¿right implant accidentally cut on back table when cutting capsule¿.Device has been explanted.
Event or Problem Description
Healthcare professional reported a right side implant exchange from textured to smooth due to the concerns of the product.Healthcare professional later reported a capsular contracture, baker grade iv, ¿capsule and consists of white plastic material grossly resembling a breast capsule", "benign lymphohistiocytic inflammation", "right breast seroma fluid from intracapsular layer and consists of yellow fluid¿ and ¿right implant accidentally cut on back table when cutting capsule¿.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint 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.¿ seroma-late: unable to observe as it is not related to the device.¿ rupture ndr: not applicable as the event is not related to the device.¿ use error: one opening on anterior side assessed as surgical damage.¿ inflammation/irritation: unable to observe as it is not related to the device.Additional observations: ¿ wear abrasion observed.¿ creases were observed.No further actions are required as no manufacturing issues are observed.

• Brand Name: INSPIRA TEXTURED 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17821172
• Report Number: 9617229-2023-15455
• Device Sequence Number: 11372615
• Product Code: FTR
• UDI-Device Identifier: 10888628033979
• UDI-Public: 10888628033979
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 04/26/2022
• Device Catalogue Number: TSM-445
• Device Lot Number: 3059471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2017
• 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
• Patient Weight: 79 KG