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

Catalog Number	FM-410350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a right side rupture.Device has been explanted.
Event or Problem Description
Health professional additionally reported "any creases.".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: deformation, voids, wear abrasion and fold creases.Cloudy after autoclave disinfection process in the gel.A weight test of the device was verified and the device was within specification.Creases/folding of implant condition that was indicated in the complaint was observed, nevertheless it is considered non-related to the manufacturing process, since the device was received out of their primary packaging and is an explanted device.Based on the device analysis the final assessment is creases/folding of implant condition was observed, nevertheless is not related to the manufacturing process and no openings were observed on the device or issues related with the complaint (rupture).

• 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: 8624848
• Report Number: 9617229-2019-03624
• Device Sequence Number: 2293157
• Product Code: FTR
• UDI-Device Identifier: 10888628002852
• UDI-Public: 10888628002852
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 10/05/2020
• Device Catalogue Number: FM-410350
• Device Lot Number: 2827026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: 63 YR