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

Model Number	TRX-340
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
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 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 due to rupture, capsular contracture baker grade unknown.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side "appears mildly deformed and there is impression of capsular separation, capsular contracture, baker grade unknown, rupture and nodular tissue.The device remains implanted.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Additional, changed, and/or corrected data: h.6., a.2.
Event or Problem Description
Healthcare professional reported a left side "appears mildly deformed and there is impression of capsular separation, rupture and nodular tissue.The device has been explanted.
Event or Problem Description
Patient representative further reported, "increased risk of alcl".Also reported, was "personal injuries and related damages", which has been deemed not related to the device.

• 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
• MDR Report Key: 8728125
• Report Number: 9617229-2019-08286
• Device Sequence Number: 1859714
• Product Code: FTR
• UDI-Device Identifier: 10888628008489
• UDI-Public: 10888628008489
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2021

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: 01/15/2021
• Device Model Number: TRX-340
• Device Catalogue Number: TRX-340
• Device Lot Number: 2872670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 06/03/2019; 05/26/2021
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/22/2019; 01/08/2020; 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR