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

Model Number	SRLP-490
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii.Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9, g.1, h.3, h.6.Device evaluation: visual analysis of the returned device identified; white particles in patch, bubbles in gel, weight within specification.Observed split in patch (ss) it is out of specification per qa 199.04, it is assessed as workmanship.Based on the device analysis the final assessment is: observed a split in patch assessed as workmanship.Further investigation results:the review of the documentation associated to the manufacturing process indicates that all devices with work order 2875090 were released in accordance with allergan procedures, and no anomalies were found in the documents or in the personnel training related to the reported event.According to the device analysis performed in the laboratory, it was found a split in patch area (ss) which is considered as workmanship according the qa199.04.This finding is not related with the reported event.According to the current risk documents the event of " split in patch " is a known failure mode and control measures are stablished to reduce or prevent the incidence of this event and its effects.Considering that there is not an adverse trend for this type of event (only pr# 2421755 in mar 2020) no additional actions are deemed required at this time.The issues with split in patch will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii.Device has been explanted and replaced.

• 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
• 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: 12176661
• Report Number: 9617229-2021-47702
• Device Sequence Number: 887525
• Product Code: FTR
• UDI-Device Identifier: 10888628006966
• UDI-Public: 10888628006966
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 01/25/2021
• Device Model Number: SRLP-490
• Device Catalogue Number: SRLP-490
• Device Lot Number: 2875090
• 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: 06/17/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2016
• 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