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

Model Number	MSZFF290
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924); Swollen Lymph Nodes (2093)
Date of Event	01/07/2020
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.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: rupture.
Event or Problem Description
Healthcare professional reported via regulatory agency left side rupture.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side rupture.Device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Device evaluation: visual analysis of the returned device identified: weight within specification, red particles in the gel, biological tissue with red color in the surface of the shell, wear abrasion, crease fold, and opening.A microscopic analysis was performed which identified sharp edge and with non-penetrating nicks assessed as surgical impact opening.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 edge opening with non-penetrating nicks due to surgical impact.Non-penetrating nicks.The events of capsular contracture baker grade iii and lymphadenopathy are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Event or Problem Description
Healthcare professional reported "an axillary adenopathy", "capsular contracture (baker grade iii)," and "rupture discovered by mri".

• 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: 9699807
• Report Number: 9617229-2020-01130
• Device Sequence Number: 3450148
• Product Code: FTR
• UDI-Device Identifier: 10888628004689
• UDI-Public: 10888628004689
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2020

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: 03/30/2016
• Device Model Number: MSZFF290
• Device Catalogue Number: N-27-MF130-375
• Device Lot Number: 2096946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020; 03/13/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/12/2020; 10/27/2020
• 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: 64 YR