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

Model Number	TSX-525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The events of seroma - late and lymphoma - alcl - suspected 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/will be requested.No additional information is available at this time.Reason for reoperation: seroma; cd30 positive, alk negative bia-alcl.
Event or Problem Description
Healthcare professional reported left side implant exchange from textured to smooth due to the concerns of the product and left side recurrent seroma.A fine needle aspiration of the seroma was performed and pathology returned the results of "rare atypical cells seen".The device has been explanted and capsulectomy performed.Pathology of left breast capsule showed the tumor cells to be cd30 positive, alk negative breast implant associated anaplastic large cell lymphoma.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of anxiety-product/procedure, seroma-late and lymphoma-alcl was received on november 21, 2022 with lot number 3022159.Based on the device analysis grid, the assessments of the complaint are: ¿ anxiety-product/procedure: unable to observe as it is a medical event that is not related to the device.¿ seroma-late: unable to observe as it is a medical event that is not related to the device.¿ lymphoma-alcl: unable to observe as it is a medical event that is not related to the device.Additional observations: ¿ deformation is observed.¿ crystalline is observed.¿ yellow particles are observed.No further actions are required as the device was implanted.
Event or Problem Description
Healthcare professional reported left side implant exchange from textured to smooth due to the concerns of the product and left side recurrent seroma.A fine needle aspiration of the seroma was performed and pathology returned the results of "rare atypical cells seen".The device has been explanted and capsulectomy performed.Pathology of left breast capsule showed the tumor cells to be cd30 positive, alk negative breast implant associated anaplastic large cell lymphoma.

• 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: 15760435
• Report Number: 9617229-2022-20035
• Device Sequence Number: 12321813
• Product Code: FTR
• UDI-Device Identifier: 10888628034389
• UDI-Public: 10888628034389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: 01/09/2022
• Device Model Number: TSX-525
• Device Catalogue Number: TSX-525
• Device Lot Number: 3022159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 63 KG