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

Model Number	SCF-295
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	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a right side rupture.Device remains implanted.
Additional Manufacturer Narrative
Reporter email address: (b)(6).A review of the device history record has been/will be initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.The reason for reoperation is: rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h10.The event of capsular contracture baker grade iii is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional reported a right side rupture.Healthcare professional later also reported capsular contracture baker grade iii.Healthcare professional later also reported "mild swelling".Device has been explanted and replaced.
Event or Problem Description
Rupture was confirmed to not be device related.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe since it is a medical event and is not related to the device.Edema-ndr: not applicable as the event is not related to the device.Rupture-ndr: not applicable as the event is not related to the device.Additional observations: deformation is observed.Wear abrasion is observed.White particles were observed on the shell.No further actions are required since no issue in the manufacturing of the device is observed.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.
Event or Problem Description
Healthcare professional reported a right side rupture.Healthcare professional later also reported capsular contracture baker grade iii.Healthcare professional later also reported "mild swelling".Rupture was confirmed to not be device related.Device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 16808845
• Report Number: 9617229-2023-07067
• Device Sequence Number: 12288404
• Product Code: FTR
• UDI-Device Identifier: 10888628030060
• UDI-Public: 10888628030060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 08/07/2023
• Device Model Number: SCF-295
• Device Catalogue Number: SCF-295
• Device Lot Number: 3249693
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 05/15/2023; 07/29/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/05/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2018
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 68 KG