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

Catalog Number	FF-410475
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of capsular contracture 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: capsular contracture baker grade iv, textured implants, dissatisfaction with implant size, lateral displacement.
Event or Problem Description
Healthcare professional reported a left side exchange due to "textured implants." healthcare professional additionally noted "pre-op and post op diagnosis implant exchange-dissatisfaction with implant size, lateral displacement and capsular contracture".Healthcare professional later reported capsular contracture baker grade iv.The device has been explanted and replaced.
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.Visual analysis of the photographs identified: capsular contracture: unable to observe as it is not related to the device.Anxiety ¿ product/ procedure: unable to observe as it is not related to the device.Unsatisfactory result: unable to observe as it is not related to the device.Flipping: unable to observe as it is not related to the device.No additional observations.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported a left side exchange due to "textured implants." healthcare professional additionally noted "pre-op and post op diagnosis implant exchange-dissatisfaction with implant size, lateral displacement and capsular contracture".Healthcare professional later reported capsular contracture baker grade iv.The device has been explanted and replaced.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18802456
• Report Number: 9617229-2024-03338
• Device Sequence Number: 15286528
• Product Code: FTR
• UDI-Device Identifier: 10888628002692
• UDI-Public: 10888628002692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 07/14/2017
• Device Catalogue Number: FF-410475
• Device Lot Number: 2329734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2012
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 56 KG