MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MX-410325
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
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.The reasons for reoperation are capsular contracture, baker grade unknown with pain, swelling, and rotated device.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported right side "rotated" device, "swollen and tender" and capsular contracture, baker grade unknown.Patient indicated the rotation had been previously treated with "corrective manipulation".Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported a right side rupture during a bilateral removal of implants.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: underweight, broken shell and red particles.A visual and microscopic analysis was performed which identified sharp broken on posterior and missing shell and orientation dot.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis, the final assessment is a sharp broken on posterior due to an unidentified (tear) opening and missing shell and orientation dot due to inconclusive.
Event or Problem Description
Additionally, patient reported right side "rotated" device, "swollen and tender" and capsular contracture, baker grade unknown.Patient additionally reported "while scraping silicone out of my breast, the doctor hit an artery"; this event is not device related.Healthcare professional reported right side, malposition, discomfort, silicone gel in pocket, removal due to patient¿s concern with the product, "torn shell" and "rupture noted in surgery".Healthcare professional also reported blood loss; this event is not device related.Device has been explanted.

• Brand Name: STYLE 410 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; CS
• MDR Report Key: 8927647
• Report Number: 9617229-2019-10648
• Device Sequence Number: 18892645
• Product Code: FTR
• UDI-Device Identifier: 10888628003729
• UDI-Public: 10888628003729
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2020

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: 03/07/2021
• Device Model Number: MX-410325
• Device Catalogue Number: MX-410325
• Device Lot Number: 2898595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 12/31/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 57