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

Model Number	TRL-290
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	05/17/2019
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 reason for reoperation is rupture.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 rupture.Device remains implanted.
Event or Problem Description
Additionally, healthcare professional reported via rga, "any creases".The device was explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified deformation of the device, creases fold, wear abrasion, non-penetrating nicks and weight of the device was found to be within specification.Cloudiness and bubbles in the gel were observed after autoclave cycle.The unit is not ruptured.Based on the device analysis the final assessment is creases are observed but have no relationship with manufacturing, and no issues found related with the manufacturing process.
Event or Problem Description
Healthcare professional reported a left side rupture and "any creases".Device was explanted.
Additional Manufacturer Narrative
Continued h6.Health effect impact code: f2203.
Event or Problem Description
Healthcare professional additionally reported capsular contracture baker grade unknown, "second capsule," inflammation,¿ and ¿tenderness and pain in left breast.¿.

• 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: 8739467
• Report Number: 9617229-2019-07309
• Device Sequence Number: 1679891
• Product Code: FTR
• UDI-Device Identifier: 10888628007710
• UDI-Public: 10888628007710
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2021

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: 06/27/2020
• Device Model Number: TRL-290
• Device Catalogue Number: TRL-290
• Device Lot Number: 2781198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 09/12/2019; 02/09/2021
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 09/18/2019; 10/10/2019; 03/09/2021
• 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: 39 YR