MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 363 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	363LF-300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/05/2019
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.Reason for reoperation: deflation.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a right-side deflation.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified creases flat, delamination valve, and delamination plug strap disk shell.Leak test and microscopic analysis were performed which identified total delamination of the valve, and total delamination of the plug strap disk shell.Based on the device analysis the final assessment was total delamination of the valve and plug strap disk shell due to adhesive failure.
Event or Problem Description
Healthcare professional reported a right-side deflation.Device was explanted.

• Brand Name: STYLE 363 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8960645
• Report Number: 9617229-2019-12668
• Device Sequence Number: 16784775
• Product Code: FWM
• UDI-Device Identifier: 10888628000995
• UDI-Public: 10888628000995
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 04/07/2020
• Device Catalogue Number: 363LF-300
• Device Lot Number: 2908511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR