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.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 and deflation.
Event or Problem Description
Patient reported right side exchange from textured to smooth implants due to the patients concerns with the product.Additionally, healthcare professional reported right side "capsular contracture, baker grade iv" and "deflation." device was explanted.
Event or Problem Description
Patient reported right side exchange from textured to smooth implants due to the patients concerns with the product.Additionally, healthcare professional reported right side "capsular contracture, baker grade iv" and "deflation." device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: "analysis of the returned device identified: opening curved on anterior and delamination plug strap disk shell.Leak test and microscopic analysis was performed which identified: striated opening on anterior, delamination partial of the plug strap disk shell, creases fold and wear abrasion.The fill test inspection was performed, and the result is no blockage.Based on the device analysis the final assessment is: a striated opening on anterior assessed as surgical damage and a delamination partial of the plug strap disk shell (cohesive failure)." trend analysis: "review of all complaints of a050401 - fluid leak for the period of jun 2020 through may 2022 related to date opened indicates that 1 point is above the upper control limit.According to the severity, an additional analysis was performed to review the involved complaints with manufacturing date over the past 24 months.Review of all complaints of a1401 - deflation problem for the period of jun 2020 through may 2022 related to date opened indicates that 7 points are above the upper control limit.According to the severity, an additional analysis was performed to review the involved complaints with manufacturing date over the past 24 months.No patterns were found; therefore, no additional actions are deemed required.The trend of a050401 - fluid leak and a1401 - deflation problem complaints will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.".

• 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: 14990624
• Report Number: 9617229-2022-11433
• Device Sequence Number: 1674618
• Product Code: FWM
• UDI-Device Identifier: 10888628000919
• UDI-Public: 10888628000919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/29/2022

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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/29/2022
• 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
• Patient Ethnicity: Hispanic