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-410360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side "exchange of textured breast implants due to the patient¿s concern with the product" and "fluid build up in the left side cavity per mri and swelling." healthcare professional additionally reported "positive alcl diagnosis." cytology report provided "the tumor cells are diffusely positive for cd45, cd3, cd30, and gata3, and negative for ae1/ae3 and ck7." pathological marker confirming alk- has not been received.Device has been explanted.
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The events of seroma and lymphoma-alcl-suspected are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "exchange of textured breast implants due to the patient¿s concern with the product," "fluid build up in the left side cavity per mri and swelling," and "positive alcl diagnosis.".
Additional Manufacturer Narrative
Additional healthcare professional contact information: oncologist dr.(b)(6), phone number: (b)(6).Device evaluation: visual analysis of the returned device identified: weight to the spec, opening, crease fold, wear abrasion.A microscopic analysis was performed which identify a striated edge opening.Based on the device analysis the final assessment is: a striated edge opening on radius side assessed as surgical damage.
Event or Problem Description
Healthcare professional reported left side "exchange of textured breast implants due to the patient¿s concern with the product" and "fluid build up in the left side cavity per mri and swelling." healthcare professional additionally reported "positive alcl diagnosis." cytology report provided "the tumor cells are diffusely positive for cd45, cd3, cd30, and gata3, and negative for ae1/ae3 and ck7." pathological marker confirming alk- has not been received.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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14053499
• Report Number: 9617229-2022-05627
• Device Sequence Number: 4766213
• Product Code: FTR
• UDI-Device Identifier: 10888628002975
• UDI-Public: 10888628002975
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 01/07/2022
• Device Model Number: FX-410360
• Device Catalogue Number: FX-410360
• Device Lot Number: 3019120
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 108 KG