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

Model Number	TSX-495
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 unknown.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported right side "capsular contracture," baker grade unknown and an "exchange from textured to smooth breast implants due to the patient¿s concern with the product." device remains implanted.
Event or Problem Description
Healthcare professional reported right side "capsular contracture," baker grade unknown and an "exchange from textured to smooth breast implants due to the patient¿s concern with the product." device remains implanted.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iii.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6(b), h6.
Event or Problem Description
Healthcare professional reported, right side "capsular contracture", baker grade iii.And an "exchange from textured to smooth breast implants, due to the patient¿s concern with the product".And "any creases".The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, fold creases and wear abrasion.A weight test of the device was verified, and the device was within specification.Cloudy after autoclave disinfection process in the gel.Creases/folding of implant condition that was indicated, in the complaint was observed.Nevertheless, it is considered non-related to the manufacturing process, since the device was received out of their primary packaging.And is an explanted device.Based on the device analysis, the final assessment is: creases/folding of implant condition was observed.Nevertheless, is not related to the manufacturing process.

• 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: 9121965
• Report Number: 9617229-2019-14494
• Device Sequence Number: 14034340
• Product Code: FTR
• UDI-Device Identifier: 10888628034372
• UDI-Public: 10888628034372
• 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: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2022

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: 01/07/2022
• Device Model Number: TSX-495
• Device Catalogue Number: TSX-495
• Device Lot Number: 3019456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/13/2021; 02/08/2022; 03/29/2022
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/03/2021; 03/07/2022; 04/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• 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: 42 YR
• Patient Sex: Female