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

Catalog Number	TRM-345
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side "implant have been recalled." patient additionally reported "pain." healthcare professional later reported "capsular contracture baker grade iv, leaking, tenderness, and rupture." device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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, pain, anxiety-product/procedure.
Additional Manufacturer Narrative
Visual analysis: visual analysis of the photographs identified: rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.Capsular contracture: unable to observe as it is not related to the device.Anxiety ¿ product/ procedure: unable to observe as it is not related to the device.No additional observations.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported right side "implant have been recalled." patient additionally reported "pain." healthcare professional later reported "capsular contracture baker grade iv, leaking, tenderness, and rupture." device has been explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data.
Event or Problem Description
Device has been explanted and replaced.
Event or Problem Description
Device received is non-abbvie device.

• 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 ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18582093
• Report Number: 9617229-2024-11045
• Device Sequence Number: 15209180
• Product Code: FTR
• UDI-Device Identifier: 10888628008106
• UDI-Public: 10888628008106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2024

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: 09/13/2021
• Device Catalogue Number: TRM-345
• Device Lot Number: 2973894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 02/07/2024; 03/04/2024; 04/04/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/12/2024; 03/08/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2016
• 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 Sex: Female
• Patient Weight: 70 KG