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

Model Number	FX-410410
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/16/2020
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 and exchange from textured to smooth implants due to the patients concerns with the product.Device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to (b)(4) has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Device photo evaluation: visual analysis of the identified photos: opening in the shell and labeled as left side.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.
Event or Problem Description
Healthcare processional reported "any creases." patient representative reported patient experienced ¿mental pain,¿ ¿chronic pain, pain prior to explant procedure¿ ¿has suffered, or will suffer, painful removal procedures,¿ ¿treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast implants, along with increased risk of alcl, fear due to risk of alcl, and any condition or symptoms associated with alcl or the prevention of that issue.¿ patient representative also reported patient ¿suffered personal injuries and related damages,¿ disfigurement,¿ ¿disability,¿ ¿suffering;¿ these events are not related to the device.

• 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: 10529267
• Report Number: 9617229-2020-14509
• Device Sequence Number: 3118447
• Product Code: FTR
• UDI-Device Identifier: 10888628002982
• UDI-Public: 10888628002982
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 10/08/2021
• Device Model Number: FX-410410
• Device Catalogue Number: FX-410410
• Device Lot Number: 2984913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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 Age: 50 YR