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

Catalog Number	TRM-375
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side "capsular contracture baker grade iv, rupture and exchange from textured to smooth breast implant due to the patient¿s concern with the product." device remains implanted.
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.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: capsular contracture baker grade iv, rupture, anxiety-product/procedure.
Event or Problem Description
Un-reporting rupture, healthcare professional later reported no rupture.Device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported, left side "capsular contracture, baker grade iv.Rupture.And exchange from textured to smooth breast implants, due to the patient¿s concern with the product".Healthcare professional, later reported, no rupture.And "fluid found around implant".Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety-product/procedure: unable to observe, since it is a medical event.And is not related to the device.Capsular contracture: unable to observe, since it is a medical event.And is not related to the device.Seroma-late: unable to observe, since it is a medical event.And is not related to the device.Additional observations: deformation observed, on the device.Crease observed, on the device.No further actions are required, as no issues with the manufacturing process are observed.The event of seroma-late is a physiological complication.And analysis of the device generally does not assist allergan in determining a probable cause for this event.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17562544
• Report Number: 9617229-2023-13482
• Device Sequence Number: 6797404
• Product Code: FTR
• UDI-Device Identifier: 10888628008120
• UDI-Public: 10888628008120
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

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: 08/05/2021
• Device Catalogue Number: TRM-375
• Device Lot Number: 2952355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 09/28/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/15/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2016
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 66 KG