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

Model Number	TCLP-490
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068--001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: flat creases, deformation.And was observed after autoclave cycle: cloudy gel.A weight test of the explanted material was verified and it was within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.Further investigation results: 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 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.The sterilization run (b)(4) is not related to any additional complaint infection record reported as of today.Review of all complaints for the period of feb 2018 through jan 2020 related with gel breast implants and found no adverse trend in the event rate regarding the reported 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.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 (late onset).
Event or Problem Description
A healthcare professional noted in the operative report that a patient experienced ¿infection in breast pocket/implant¿, ¿red, swollen and very tender¿ and ¿exchange of implant due to voluntary recall (asymptomatic patient)".Device was explanted.

• Brand Name: INSPIRA TEXTURE 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: 9985410
• Report Number: 9617229-2020-06096
• Device Sequence Number: 4482848
• Product Code: FTR
• UDI-Device Identifier: 10888628030756
• UDI-Public: 10888628030756
• Combination Product (Y/N): N
• Initial Reporter State: MT
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: TCLP-490
• Device Catalogue Number: TCLP-490
• Device Lot Number: 3022718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 04/22/2020
• 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: 63 YR