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

Catalog Number	TRM-360
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	04/15/2019
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.The event of capsular contracture and seroma-late are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: "fluid around the implant", "swelling", "pain", looking "strange and shaped differently", suspicion of breast implant associated anaplastic large cell lymphoma (bia-alcl.) 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 capsular contracture, baker grade iii, "fluid around the implant", "swelling", "pain", looking "strange and shaped differently." device was explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: deformation, black particles, encapsulation and creases.Cloudy and bubbles after autoclave disinfection process in the gel.A weight test of the device was verified and the device was within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing.
Event or Problem Description
Healthcare professional reported left-side capsular contracture, baker grade iii, "fluid around the implant", "swelling", "pain", looking "strange and shaped differently." device was 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: 8714016
• Report Number: 9617229-2019-07162
• Device Sequence Number: 2663559
• Product Code: FTR
• UDI-Device Identifier: 10888628008113
• UDI-Public: 10888628008113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 02/21/2021
• Device Catalogue Number: TRM-360
• Device Lot Number: 2887963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: 62 YR