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

Catalog Number	TCF-335
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 22/jan/2019.A review of the device history record has been completed.No deviations or non-conformances noted.The reason for reoperation was capsular contracture, baker grade iii.Device evaluation: visual analysis of the returned device identified deformation, yellow particles, and fold creases.Cloudiness in the gel was observed after autoclave cycle:.A weight test of the explanted material was completed and found it to be within specification.Based on the device analysis the final assessment is no issues found related with the manufacturing process, and visual analysis reported deformation, fold creases and weight within specification.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a left side capsular contracture baker grade iii, and ¿exchange from textured to smooth breast implants due to the patient¿s concern with the product¿.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: 9296751
• Report Number: 9617229-2019-16654
• Device Sequence Number: 2509732
• Product Code: FTR
• UDI-Device Identifier: 10888628031081
• UDI-Public: 10888628031081
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/08/2019

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: 08/12/2021
• Device Catalogue Number: TCF-335
• Device Lot Number: 2961116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/08/2019
• 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: 35 YR