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

Model Number	TRX-445
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930); Seroma (2069); Lymphoma (3263)
Date of Event	04/02/2020
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.The event of "seroma" 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: seroma-late.
Event or Problem Description
Healthcare professional reported right side "significant swelling of right breast", "significant amount of edema", and "swelling in surrounding breast tissue." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: weight to the spec, crease fold, deformation.Cloudy and bubbles were observed after autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Healthcare professional reported right side "significant swelling of right breast", "significant amount of edema", and "swelling in surrounding breast tissue." device has been explanted.
Event or Problem Description
Patient representative reported patient experienced "seroma, extreme swelling," "anxiety, mental and emotional suffering, fear, grief, anxiety, apprehension, anguish and fear due to risk of bia-alcl," "diagnosis of bia-alcl," capsular contracture, baker grade unknown, "heat sensation," "significant pain," "rashes, itching," "infection," "change in nipple sensation".Histopathological markers confirming alcl have not been received.Treatment: device explant, capsulectomy, chemotherapy.
Additional Manufacturer Narrative
Continued h.6 (health effect - impact code): f2303.

• 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: 10017363
• Report Number: 9617229-2020-06904
• Device Sequence Number: 2168054
• Product Code: FTR
• UDI-Device Identifier: 10888628008526
• UDI-Public: 10888628008526
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2021

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: 08/30/2020
• Device Model Number: TRX-445
• Device Catalogue Number: TRX-445
• Device Lot Number: 2805806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 04/23/2021
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/25/2020; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2015
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic