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

Model Number	TRM-255
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	02/15/2019
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 is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The 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
Patient reported left side "contracture," pain, and it "feels like needle is poking them." healthcare professional reported capsular contracture, baker grade iii.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Event or Problem Description
Device explanted.Lab analysis pending.
Event or Problem Description
Patient reported, left side "contracture" pain.And it "feels like needle is poking them".Healthcare professional reported, capsular contracture, baker grade iii.Device explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified, opening on posterior, crease fold, yellow particles in the shell and weight to the spec.A visual and microscopic analysis was performed which identified, striated opening on posterior and crease sharp on posterior.Base on the device analysis, the final assessment is: a striated opening assessed, as surgical damage.An opening crease sharp on posterior assessed, as fold flaw opening.
Event or Problem Description
Patient reported left side "contracture," pain, and it "feels like needle is poking them." healthcare professional reported capsular contracture, baker grade iii.Healthcare professional additional reported "appeared to be ruptured".Device has been explanted and replaced.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 8951452
• Report Number: 9617229-2019-13421
• Device Sequence Number: 19437540
• Product Code: FTR
• UDI-Device Identifier: 10888628008052
• UDI-Public: 10888628008052
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2022

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: TRM-255
• Device Catalogue Number: TRM-255
• Device Lot Number: 2890749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 10/21/2021; 11/18/2021; 03/15/2022
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/10/2021; 12/09/2021; 04/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 138 KG