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

Model Number	TRF-605
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
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 iii.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported left side "knots under left armpit," and pain.Healthcare professional reported left side capsular contracture, baker grade iii.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified the device was broken shell, fold creases, red particles material was found on the shell/gel, white encapsulation and missing shell.A weight test of the device was verified and the device underweight.A microscopic analysis was performed which identified broken striated and wear abrasion.Based on the device analysis the final assessment is: a striated edge broken in the side anterior assessed as surgical damage.Missing shell assessed as inconclusive.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis the final assessment is: a striated edge broken in the side anterior assessed as surgical damage.Missing shell assessed as inconclusive.
Event or Problem Description
Healthcare professional additionally reported rupture.

• 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 8932872
• Report Number: 9617229-2019-12497
• Device Sequence Number: 242792
• Product Code: FTR
• UDI-Device Identifier: 10888628008380
• UDI-Public: 10888628008380
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 01/10/2021
• Device Model Number: TRF-605
• Device Catalogue Number: TRF-605
• Device Lot Number: 2869264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 04/25/2022; 01/11/2023
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 05/17/2022; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2016
• 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 Sex: Female