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

Catalog Number	168-550
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.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 left side deflation and capsular contracture, baker grade ii.Device remains implanted.
Additional Manufacturer Narrative
The reason for reoperation: deflation.
Event or Problem Description
Patient additionally reported "exhaustion" and "fatigue", "autoimmune issues", "hashimoto's thyroid" and "brain fog"; these events are not related to the device.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: delamination of plug strap disk shell and one curved opening.A leak test was performed which identified opening.A microscopic analysis was performed which identify: one sharp opening and delamination of plug strap disk shell.A dimension measurement in the shell was performed which identify the thickness within specification.Fill inspection was performed and identified no blockage in the valve.Based on the device analysis the final assessment is: one sharp opening assessed as unidentified (tear) opening and partial delamination of plug strap disk shell due to adhesive failure.
Event or Problem Description
Healthcare professional reported left side deflation and capsular contracture, baker grade ii.Patient additionally reported "exhaustion" and "fatigue", "autoimmune issues", "hashimoto's thyroid" and "brain fog"; these events are not related to the device.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: 8338897
• Report Number: 9617229-2019-00754
• Device Sequence Number: 206876
• Product Code: FWM
• UDI-Device Identifier: 10888628000896
• UDI-Public: 10888628000896
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2019

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: 06/15/2019
• Device Catalogue Number: 168-550
• Device Lot Number: 2776393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 07/19/2019; 08/22/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 08/16/2019; 09/20/2019
• 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: 35 YR