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-410255
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Lymphoma (3263); Swollen Lymph Nodes/Glands (4432)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side rupture, exchange from textured to smooth breast implants due to the patient¿s concern with the product, "abnormal left axillary lymph node finding," and "alcl." patient also reported "nauseous" and "joints hurt"; these events are not related to the device.Healthcare professional later reported rupture and "abnormal left axillary lymph node and prominent folding along the edge of the left implant." pathological markers confirming alcl have 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-suspected and lymphadenopathy 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: rupture, exchange from textured to smooth breast implants due to the patient¿s concern with the product, "abnormal left axillary lymph node finding," and "alcl suspected".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: underweight, broken shell, red particles on the shell, crease flat, and missing a piece of shell (0-25%).A microscopic analysis was performed which identified: two sharp broken on posterior.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: two sharp broken on posterior assessed as unidentified (tear) opening.Missing shell assessed as inconclusive.Crease/folding of implant condition was observed, nevertheless it is not related to the manufacturing process.
Event or Problem Description
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: 14463157
• Report Number: 9617229-2022-08465
• Device Sequence Number: 19976031
• Product Code: FTR
• UDI-Device Identifier: 10888628003446
• UDI-Public: 10888628003446
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 10/16/2020
• Device Model Number: MF-410255
• Device Catalogue Number: MF-410255
• Device Lot Number: 2833780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG