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

Model Number	TRX-495
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Reason for reoperation: capsular contracture, baker grade iii.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 a right side capsular contracture baker grade iii.Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported a right side rupture.The device was explanted.
Additional Manufacturer Narrative
Device evaluation: visual and microscopic analysis of the returned device identified: around 0-25% of the shell is missing, broken shell with sharp edge(a dimension measurement in the shell was performed which identify the thickness within specification), flat creases and a weight test of the explanted material was verified and it was underweight.Based on the device analysis the final assessment is: broken shell with sharp edge assessed as unidentified(tear) opening.Missing shell that is assessed as inconclusive.
Event or Problem Description
Healthcare professional reported a right side capsular contracture, baker grade iii, and rupture.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: 8936592
• Report Number: 9617229-2019-11188
• Device Sequence Number: 18961189
• Product Code: FTR
• UDI-Device Identifier: 10888628008540
• UDI-Public: 10888628008540
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 01/29/2020

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: 04/10/2017
• Device Model Number: TRX-495
• Device Catalogue Number: N-TRX495
• Device Lot Number: 2269188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 01/06/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 12/30/2019; 01/29/2020
• 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: 37 YR