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

Catalog Number	27-FF115-290
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zip code: (b)(6).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: "textured implant", "swollen right breast", "leaking right breast implant with some free fluid external to the right breast implant capsule".
Event or Problem Description
Healthcare professional reported right side "textured implant", "swollen right breast", "ultrasound suggested evidence of leaking right breast implant with some free fluid external to the right breast implant capsule".Device remains implanted.
Additional Manufacturer Narrative
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.Contact information/ names of other hcps who would have information on the case: (b)(6).
Event or Problem Description
Healthcare professional reported bia-alcl on right side.Pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device has been explanted.
Additional Manufacturer Narrative
Visual device evaluation: visual analysis of the photographs identified red particle material on the shell and red encapsulation.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.Additional, changed, and/or corrected data: h.6.
Event or Problem Description
Healthcare professional reported right side "textured implant", "swollen right breast", "ultrasound suggested evidence of leaking right breast implant with some free fluid external to the right breast implant capsule".Healthcare professional reported bia-alcl on right side.Pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12362410
• Report Number: 9617229-2021-49377
• Device Sequence Number: 3925969
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2022

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: 07/08/2013
• Device Catalogue Number: 27-FF115-290
• Device Lot Number: 1624622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 01/18/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/11/2022; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2008
• 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: 60 YR
• Patient Sex: Female