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-410375
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924); Seroma (2069)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side rupture.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.Visual analysis: device photograph(s) for the device related to the reported event capsular contracture and seroma-late was reviewed on may 11, 2023.Visual analysis of the photographs identified: capsular contracture: 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.It is not possible to determine the lot number or catalog through the photos provided.Device photograph(s) for the device related to the reported event capsular contracture and seroma-late was reviewed on may 11, 2023.Visual analysis of the photographs identified: capsular contracture: 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.It is not possible to determine the lot number or catalog through the photos provided.
Event or Problem Description
Healthcare professional later reported capsule appeared to be grade ii-iii and no rupture was found.As noted in the operative report, periprosthetic fluid on the right side was aspirated and sent for cytology.Device has been explanted.
Event or Problem Description
Healthcare professional later reported capsule appeared to be grade ii-iii and no rupture was found.As noted in the operative report, periprosthetic fluid on the right side was aspirated and sent for cytology.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ capsular contracture: unable to confirm as it is a medical event not related to the device.¿ seroma-late: unable to confirm as it is a medical event not related to the device.Additional observations: ¿ deformation observed in the device.¿ brown particles observed in the device.

• 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: 16516708
• Report Number: 9617229-2023-02946
• Device Sequence Number: 6129199
• Product Code: FTR
• UDI-Device Identifier: 10888628002678
• UDI-Public: 10888628002678
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

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: 10/27/2019
• Device Model Number: FF-410375
• Device Catalogue Number: FF-410375
• Device Lot Number: 2678834
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 07/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/24/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2014
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 61 KG