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

Model Number	TRL-350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2019
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.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: rupture.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported right side rupture.Device remains implanted.
Event or Problem Description
The device was explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Healthcare professional reported right side rupture.Device remains implanted.
Additional Manufacturer Narrative
This report is submitted beyond 30 calendar days from allergan¿s receipt due to a system error preventing allergan from submitting reports via emdr.The system error has been resolved at this time and an investigation has been initiated into this occurrence.Device evaluation: visual analysis of the returned device identified: one extended opening, black/yellow particle material was found on the shell and flat creases.A weight test of the device was performed and verified and the device underweight.A microscopic analysis was performed which identified a sharp edge opening in the shell with stress marks assessed as surgical impact opening.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis.The final assessment is a sharp edge opening in the shell with stress marks assessed as a surgical impact opening.Additional, corrected, and/or changed data: b.7., h.3, h.6.
Event or Problem Description
Healthcare professional reported right side rupture.The 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: 9390020
• Report Number: 9617229-2019-19512
• Device Sequence Number: 1833871
• Product Code: FTR
• UDI-Device Identifier: 10888628007734
• UDI-Public: 10888628007734
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/13/2020

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: 02/28/2021
• Device Model Number: TRL-350
• Device Catalogue Number: TRL-350
• Device Lot Number: 2890540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 01/31/2020; 03/04/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 01/27/2020; 02/28/2020; 04/13/2020
• 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: 60 YR