MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-450
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The device has been explanted.
Event or Problem Description
Healthcare professional reported right side "textured saline implants, "recently noticed a change in the size of breasts", "suspect leaking", and capsular contracture baker grade iii.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: no observed.Capsular contracture : unable to observe since it is a medical event and is not related to the device.Anxiety-product/procedure : unable to observe since it is a medical event and is not related to the device.Particles in valve: no observed.Calcification : observed.Crease folding/of implant : observed.No additional observation.No further actions are required as no issues with the manufacturing process are observed.Peer/ supervisor reviewer.
Event or Problem Description
Healthcare professional reported, right side "textured saline implants."recently noticed, a change in the size of breasts"."suspect leaking".And capsular contracture, baker grade iii.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; capsular contracture, baker grade iii.

• Brand Name: STYLE 468 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 f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18804397
• Report Number: 9617229-2024-03373
• Device Sequence Number: 12554873
• Product Code: FWM
• UDI-Device Identifier: 10888628001145
• UDI-Public: 10888628001145
• 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: 2001
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2004
• Device Catalogue Number: 468-450
• Device Lot Number: 559094
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 05/04/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/10/2024; 05/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2001
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White