MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	MF-410420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of infection 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: infection this is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported implant exchange" due to an infection".The patient additionally reported "breast cancer" which is not device related.The device was explanted.This record is for the left side.
Additional Manufacturer Narrative
Further investigation result(s): with the information collected during the investigation, there is enough evidence to support that device serial number (b)(4) was manufactured under controlled conditions in accordance with allergan medical procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.One additional complaint was noted for devices sterilized under sterilization run 30017441.However, it is unlikely that the events related to the reported infection are associated to the sterilization methods utilized.The terminal sterilization cycle used by allergan was developed and validated to achieve a high level of sterility assurance.The sterilization cycle has been validated to assure that the chance of a non-sterile device is less than one in a million.During the trend review of all infection complaints for gel breast implants for the period of sep 2017 through aug 2019, was noted an outlier in november 2017.An additional analysis was performed to determine any pattern or any similarities relation between pr¿s involved.It was found that some primary packaging operators were involved in more than one occasion, however the people were trained in the corresponding procedure.Also, calibrations, maintenance and validations of the equipments involved in more than one occasion were reviewed and it was determined that they were performed on time and met specifications.In addition, all the records involved in this month was reviewed and no issues, deviations or ncs were found associated to either event.Given the fact that the cause of the infection cannot be specifically associated to (b)(4) manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.
Event or Problem Description
Patient reported implant exchange" due to an infection".The patient additionally reported "breast cancer" which is not device related.The device was explanted.This record is for the left side.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9117807
• Report Number: 9617229-2019-15277
• Device Sequence Number: 1848640
• Product Code: FTR
• UDI-Device Identifier: 10888628003484
• UDI-Public: 10888628003484
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 10/28/2019
• Device Catalogue Number: MF-410420
• Device Lot Number: 2678883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/29/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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