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

Model Number	TCLP-280
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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 events of infection and capsular contracture are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: swelling, pain, deformity, hardening, capsular contracture, baker grade unknown, fever, immediately hospitalized with a serious infection and bilateral swelling of the breast wall, significant breast pain.
Event or Problem Description
Patient representative reported that the patient experienced swelling, pain, deformity, hardening, capsular contracture, baker grade unknown, fever, immediately hospitalized with a serious infection and bilateral swelling of the breast wall, significant breast pain and "both implants were textured from information and belief, which from information and belief were also recalled in the later recall by the fda." the reported events of lumps and body aches have been deemed not related to the device.This record is for the right side.The device has been explanted and replaced.
Additional Manufacturer Narrative
Further investigation summary: with the information collected during the investigation, there is enough evidence to support that device lot number 2961172 was manufactured under controlled conditions in accordance with abbvie¿s procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.One additional complaint was noted for devices sterilized under sterilization run 30024442.However, it is unlikely that the events related to the reported infection are associated to the sterilization methods utilized.The terminal sterilization cycle used by abbvie was developed and validated to achieve a high level of sterility assurance.The sterilization cycle has been validated to assure that the chance of a non-sterile device is less than one in a million.During the trend review of all infection complaints for the period of (b)(6)2020 through (b)(6)2022, no adverse trend was noted.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.
Event or Problem Description
Patient representative reported that the patient experienced swelling, pain, deformity, hardening, capsular contracture, baker grade unknown, fever, immediately hospitalized with a serious infection and bilateral swelling of the breast wall, significant breast pain and "both implants were textured from information and belief, which from information and belief were also recalled in the later recall by the fda." the reported events of lumps and body aches have been deemed not related to the device.This record is for the right side.The device has been explanted and replaced.

• Brand Name: INSPIRA TEXTURE 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: 14934160
• Report Number: 9617229-2022-05046
• Device Sequence Number: 17550684
• Product Code: FTR
• UDI-Device Identifier: 10888628030688
• UDI-Public: 10888628030688
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 08/20/2021
• Device Model Number: TCLP-280
• Device Catalogue Number: TCLP-280
• Device Lot Number: 2961172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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