MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	168-390
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare provider reported patient has textured mammary implants and a right side capsular contracture baker grade iii and that the right implant may also be leaking.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: deflation and capsular contracture, baker grade iii.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Event or Problem Description
Healthcare provider reported patient has textured mammary implants and a right-side capsular contracture baker grade iii and that the right implant may also be leaking.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ crease/folding of implant: observed creases on device.¿ deflation: not observed.¿ particles in valve: not observed.No additional observations performed on the device.No further actions are required.
Event or Problem Description
Healthcare professional additionally reported particles in valve, plug strap separated, and creases.
Event or Problem Description
Healthcare professional reported right side textured mammary implant and a capsular contracture baker grade iii and that the implant may also be leaking.Healthcare professional additionally reported "observations made during surgery" of "any creases," "valve area: particles in valve," and "plug strap separated." the device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ crease/folding of implant: observed creases on device.¿ deflation: not observed.¿ particles in valve: not observed.¿ plug strap separated: not observed.No additional observations performed on the device.No further actions are required.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 20206234
• Report Number: 9617229-2024-20585
• Device Sequence Number: 7643218
• Product Code: FWM
• UDI-Device Identifier: 10888628000841
• UDI-Public: 10888628000841
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2011
• Device Catalogue Number: 168-390
• Device Lot Number: 1548859
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/21/2024; 12/09/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/27/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2008
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White