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

Model Number	MF-410640
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported unknown side "confirmed alcl." healthcare professional additionally reported right side rupture, and seroma.Pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The events of lymphoma - alcl and seroma-late are physiological complications 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: rupture, seroma-late, and lymphoma-alcl.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified the weight the device within specification, black particles in the shell and deformation.Cloudy and voids in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing.
Event or Problem Description
Healthcare professional reported right side "confirmed alcl", "rupture", "seroma".Pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device has been explanted.
Event or Problem Description
Healthcare professional reported unknown side "confirmed alcl." healthcare professional additionally reported right side rupture, and seroma.Pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device has been explanted.
Additional Manufacturer Narrative
Previous medwatch submission noted lymphoma-alcl.Upon review of received pathology reports, allergan medical safety determined that it should be reported as lymphoma-alcl-suspected.Only pathology marker cd30+ was provided.Alk- was not received.Upon review of additional information, the recall number previously reported in h.7./h.9.Should not have been submitted.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 13585062
• Report Number: 9617229-2022-02354
• Device Sequence Number: 5539917
• Product Code: FTR
• UDI-Device Identifier: 10888628003521
• UDI-Public: 10888628003521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2024

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: 06/07/2020
• Device Model Number: MF-410640
• Device Catalogue Number: MF-410640
• Device Lot Number: 2773964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 05/25/2022; 01/12/2024
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/11/2022; 06/22/2022; 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female