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

Model Number	TRF-520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	06/24/2021
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 lymphoma-alcl-suspected 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: lymphoma-alcl-suspected.
Event or Problem Description
Healthcare professional reported "patient was diagnosed with anaplastic large cell lymphoma(alcl)." pathological markers confirming alcl have not been received.The left side device was explanted.
Additional Manufacturer Narrative
The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional later reported "onset of swelling and firmness similar to patient¿s prior experience with capsular contracture.Heavy and aching feel to large left breast.Mild worsening of eczema to left nipple.Discomfort wearing support bras.Peri-implant seroma- noted on diagnostic ultrasound (b)(6) 2021.300cc of pink cloudy fluid aspirated by radiologist.".
Event or Problem Description
Healthcare professional additionally reported "cd30 expression is strong and diffusely positive," and "alk is negative.".

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13237254
• Report Number: 9617229-2021-59860
• Device Sequence Number: 14535614
• Product Code: FTR
• UDI-Device Identifier: 10888628008366
• UDI-Public: 10888628008366
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2022

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: 07/19/2021
• Device Model Number: TRF-520
• Device Catalogue Number: TRF-520
• Device Lot Number: 2949121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 05/16/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/02/2022; 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White