MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FF-410595
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter (email address): (b)(6).Date of alcl diagnosis: (b)(6) 2022.A review of the device history record has been completed.No deviations or non-conformances noted.The reported events 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.The reason for reoperation is: "alcl found on post op pathology, markers provided", and per op.Report a "recurrent seroma formation left reconstructed breast with capsular contracture grade 4".
Event or Problem Description
Healthcare professional reported left side "alcl found on post op pathology", "recurrent seroma formation", "left reconstructed breast with capsular contracture grade 4", "bilateral implant removal from textured to smooth due to the concerns of the product".Histopathological markers cd30+ and alk- have been received.The device has been explanted and replaced.Treatment: device explant, "left capsulectomy.Robotic assisted laparoscopic transabdominal preperitoneal repair of incisional hernia with mesh" and "roughly 550 cc seromatous fluid was removed".
Event or Problem Description
Healthcare professional reported left side "alcl found on post op pathology", "recurrent seroma formation", "left reconstructed breast with capsular contracture grade 4", "bilateral implant removal from textured to smooth due to the concerns of the product".Histopathological markers cd30+ and alk- have been received.The device has been explanted and replaced.Treatment: device explant, "left capsulectomy.Robotic assisted laparoscopic transabdominal preperitoneal repair of incisional hernia with mesh" and "roughly 550 cc seromatous fluid was removed".

• Brand Name: STYLE 410 COHESIVE 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: 16143281
• Report Number: 9617229-2022-23822
• Device Sequence Number: 20517367
• Product Code: FTR
• UDI-Device Identifier: 10888628002715
• UDI-Public: 10888628002715
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2023

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: 02/29/2020
• Device Model Number: FF-410595
• Device Catalogue Number: FF-410595
• Device Lot Number: 2721504
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 04/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 79 KG