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

Model Number	TRX-495
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); Fluid Discharge (2686)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - impact code: f2203.A review of the device history record has been completed.No deviations or non-conformances noted.Photo analysis: visual analysis of the photographs identified: rupture: no observed openings in the device.Visibility/palpability: unable to confirm as it is a medical event not related to the device.Drainage: unable to confirm as it is a medical event not related to the device.Lump/nodule: unable to confirm as it is a medical event not related to the device.Calcification: unable to confirm as it is a medical event not related to the device.Pain: unable to confirm as it is a medical event not related to the device.Cyst: unable to confirm as it is a medical event not related to the device.Seroma: unable to confirm as it is a medical event not related to the device.Anxiety-product/procedure: unable to confirm as it is a medical event not related to the device.It is not possible to determine the lot number or catalog through the photos provided.The events of "seroma-late" and "drainage" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: rupture; "perimplant fluid"; "filmy drainage" found at device explant.
Event or Problem Description
Healthcare professional reported left side rupture.Healthcare professional later reported a left side "deformity on the lateral portion of breast," "filmy drainage" and "slimy film across the implant," "a 5mm nodular density," "calcifications in both breasts," "left lateral breast pain," "periimplant fluid," "intracapsular rupture," "burning irritation left-sided breast," and "concern regarding implant recall." healthcare professional also reported "tiny cyst in left breast," which is not device related.Device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported left side "visible deformity", "any creases".
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: no observed openings during analysis.Visibility/palpability: unable to observe as it is a medical event not related to the device.Drainage: unable to observe as it is a medical event not related to the device.Lump/nodule: unable to observe as it is a medical event not related to the device.Calcification: white calcification observed in the surface of the shell.Pain: unable to observe as it is a medical event not related to the device.Anxiety-product/procedure: unable to observe as it is a medical event not related to the device.Inflammation/irritation: unable to observe as it is a medical event not related to the device.Seroma-late: unable to observe as it is a medical event not related to the device.Cyst-ndr: not applicable as the event is not related to the device.Crease/folding of implant: no observed creases on the device.Additional observations: yellow particles observed in the surface of the shell.Observed deformation on the device.Observed wear abrasion on 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16526627
• Report Number: 9617229-2023-03177
• Device Sequence Number: 2644835
• Product Code: FTR
• UDI-Device Identifier: 10888628008540
• UDI-Public: 10888628008540
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 08/19/2020
• Device Model Number: TRX-495
• Device Catalogue Number: TRX-495
• Device Lot Number: 2805809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2015
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG