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

Catalog Number	TRM-295
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30-calendar days from allergan¿s receipt due to the exemption transition period.Information contained in this report was previously submitted through psr on 22/apr/2019.A review of the device history record has been completed.No deviations or non-conformance's noted.Device evaluation: analysis of the returned device identified weight of the device within specification, fold creases, and a deformation.There was a cloudy color observed in the gel after the autoclave cycle.Based on the device analysis, the final assessment is no issues found related with the manufacturing process.The event of capsular contracture 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.The reason for reoperation is capsular contracture, baker grade iii.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii and double capsule.Device has been explanted.

• Brand Name: INSPIRA TEXTURED 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: 8654201
• Report Number: 9617229-2019-04479
• Device Sequence Number: 2286629
• Product Code: FTR
• UDI-Device Identifier: 10888628008076
• UDI-Public: 10888628008076
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: P020056
• 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

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: 12/23/2020
• Device Catalogue Number: TRM-295
• Device Lot Number: 2857580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/30/2019
• 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: 38 YR