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

Catalog Number	SRX-285
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a right side capsular contracture baker grade iii/iv.Device has been explanted.
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 iii/iv.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ capsular contracture: unable to observe.A workmanship was observed not related to the complaint for a split and patch event.A further investigation is requested.As per the investigation procedure, deformation was observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, corrected and/or changed data: d.9, h.3, h.6.
Event or Problem Description
Healthcare professional reported a right side capsular contracture baker grade iii/iv.Device has been explanted.
Additional Manufacturer Narrative
Fi summary: the review of the documentation associated to the manufacturing process indicates that all devices involved in this work order were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the device analysis performed in the laboratory was observed a workmanship (split in patch) not related to the complaint.The event of capsular contracture was unable to observed and the workmanship has not relation to reported complaint.Therefore, the reported event was not confirmed.A review of the current risk documents pfmea-silicone filled bi and sizer assy (v8.0) was performed, and the event of split in patch is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Considering that there is not an adverse trend for this type of event only (b)(4) in (b)(6) 2023 no additional actions are deemed required at this time.The issues with split in patch event will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported a right-side capsular contracture baker grade iii/iv.Device has been explanted.

• Brand Name: INSPIRA SMOOTH 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 21428640
• Report Number: 9617229-2025-03003
• Device Sequence Number: 4606047
• Product Code: FTR
• UDI-Device Identifier: 10888628007468
• UDI-Public: (01)10888628007468(10)3410280(11)200127(17)241227
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 12/08/2024
• Device Catalogue Number: SRX-285
• Device Lot Number: 3410280
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 04/24/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG