MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	20-750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/20/2020
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 remains implanted.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe as it is a medical event not related to the device.Additional observations: deformation device observed on the device.Crease fold observed on the device.White particles observed on the device.Observed split in patch area, assessed as a workmanship.No further actions are required as the device was implanted.Fi summary: the review of the documentation associated to the manufacturing process indicates that all devices with lot number 2719082 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 to this lot and the complaint.According to the device analysis performed in the laboratory, was observed split in patch area, it is out of specification per qa 199.04.According to the analysis review the reported complaint was unable to observe.However, the workmanship is not related to the reported complaint.A review of the current risk documents was performed and the event of split in patch is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.During the trend review of all split in patch complaints for gel breast implants for the period of (b)(6)2020 through (b)(6)2022, was noted an outlier in (b)(6)2020.The additional analysis performed shows all that results met the acceptance criteria and no issues, deviations or non-conformances were found which could be associated to the split in patch event, so, no additional actions are deemed required at this time.The issue with split in patch will continue to be monitored and corrective action taken in the future if deemed appropriate.

• Brand Name: STYLE 20 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 10420670
• Report Number: 9617229-2020-12872
• Device Sequence Number: 3872510
• Product Code: FTR
• UDI-Device Identifier: 10888628001794
• UDI-Public: 10888628001794
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

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: 02/21/2020
• Device Model Number: 20-750
• Device Catalogue Number: 20-750
• Device Lot Number: 2719082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/02/2022; 10/20/2022
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/28/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2015
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 86 KG