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

Model Number	TRF-485
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/15/2020
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.Device evaluation: device photograph(s) for the device related to the reported event of capsular contracture was reviewed on 25 may 2020.Visual analysis of the photographs identified red/black particles in device outer surface and encapsulation.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.Refer to ps-qp-onev-115717: covid-19 quality plan - complaint handling.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.The reason for reoperation: capsular contracture baker grade iv.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 iv.Healthcare professional reported additional event of "mild chronic inflammation".Device has been explanted.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iv.Healthcare professional reported additional event of "mild chronic inflammation".Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 10165252
• Report Number: 9617229-2020-08831
• Device Sequence Number: 3536124
• Product Code: FTR
• UDI-Device Identifier: 10888628008359
• UDI-Public: 10888628008359
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 08/21/2021
• Device Model Number: TRF-485
• Device Catalogue Number: TRF-485
• Device Lot Number: 2966204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 64 KG