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

Catalog Number	168-420
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2019
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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation is deflation.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side deflation.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified an opening on posterior, creases fold, and yellow particles.A leak test and microscopic analysis were performed which identified a striated opening due to surgical damage and consistent in the use of some surgical tool, non-penetrating nicks, a sharp opening on the radius due to an unidentified tear opening, and delamination on the valve (<75% partial separation) assessed as adhesive failure.A dimension measurement in the shell was performed which identified the thickness is within specification.
Event or Problem Description
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; CS
• MDR Report Key: 8548752
• Report Number: 9617229-2019-02685
• Device Sequence Number: 2444014
• Product Code: FWM
• UDI-Device Identifier: 10888628000858
• UDI-Public: 10888628000858
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 10/28/2018
• Device Catalogue Number: 168-420
• Device Lot Number: 2679604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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: 48 YR