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

Model Number	TRL-410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2020
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.
Event or Problem Description
Healthcare professional reported right side rupture.Device remains implanted.
Event or Problem Description
Healthcare professional reported right side rupture.Additionally, healthcare professional reported "implant with slight edema surrounding the implant capsule", "breast swelling" and "implants have been recalled".Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and / or corrected data.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, wear abrasion, voids, and overweight (the weight is out specification according to the assembly drawing (wi) qa 199.05.It was identified as a workmanship and the weight report is attached.After autoclave cycle was observed cloudy color in the gel.Based on the device analysis the final assessment is no were observed openings on the device.The weight is out specification according to the assembly drawing (wi) qa 199.05.It was identified as a workmanship.Further investigation has been initiated.Additional, changed, and/or corrected data: g2, h3, & h6.
Event or Problem Description
Healthcare professional reported right side rupture.Additionally, healthcare professional reported "implant with slight edema surrounding the implant capsule", "breast swelling" and "implants have been recalled".Device has been explanted.
Event or Problem Description
Healthcare professional reported right side rupture.Additionally, healthcare professional reported "implant with slight edema surrounding the implant capsule", "breast swelling" and "implants have been recalled".Device has been explanted.
Additional Manufacturer Narrative
Further investigation results: the review of the documentation associated to the manufacturing process indicates that all devices with work order (b)(4) were released in accordance with allergan procedures, and no anomalies were found in the personnel training related to the reported event.According to the weight verification report one unit was with an incorrect weight.Nonetheless, the assembly report from sap shows that the unit was scrapped due to weight, therefore, no devices were released with the condition of overweight.According to the device analysis performed, the device was overweight, however, after verifying the weight report and the assembly report from sap, no devices were released with the condition of overweight.A review of the current risk documents was performed, and the event of overweight is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.

• 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: 10821865
• Report Number: 9617229-2020-18256
• Device Sequence Number: 17064028
• Product Code: FTR
• UDI-Device Identifier: 10888628007758
• UDI-Public: 10888628007758
• Combination Product (Y/N): N
• Initial Reporter State: MN
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2022

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: 06/10/2020
• Device Model Number: TRL-410
• Device Catalogue Number: TRL-410
• Device Lot Number: 2773348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 02/04/2021; 09/30/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 01/13/2021; 03/07/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2015
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 78 KG