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

Model Number	168-650
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Dhr trend summary: no patterns were found; therefore, no additional actions are deemed required.The trend of a050401 - fluid leak complaints will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.The event of "capsular contracture, baker grade iv" 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 iv.
Event or Problem Description
Patient reported left side deflation and exchange from textured to smooth implants due to the patients concerns with the product.Additionally, healthcare professional reported left side "capsular contracture baker grade iv." device remains implanted.
Additional Manufacturer Narrative
Device evaluation:analysis of the returned device identified: crease flat, delamination of the plug strap disk shell and opening curved on posterior.Leak test and microscopic analysis was performed which identified: sharp opening on posterior, delamination of the plug strap disk shell and non-penetrating nick.The fill test inspection was performed, the result is no blockage.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp opening on posterior assessed as an unidentified (tear) opening.A delamination total of the plug strap disk shell (adhesive failure).
Event or Problem Description
Healthcare professional reported left side hole non specific-in inferior aspect.Device has been explanted.

• 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
• 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: 14881451
• Report Number: 9617229-2022-10807
• Device Sequence Number: 6307094
• Product Code: FWM
• UDI-Device Identifier: 10888628000919
• UDI-Public: 10888628000919
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 11/15/2019
• Device Model Number: 168-650
• Device Catalogue Number: 168-650
• Device Lot Number: 2843498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2015
• 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 Sex: Female
• Patient Weight: 73 KG