MAUDE Adverse Event Report: MENTOR TEXAS MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Catalog Number	SDC130UH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Impaired Healing (2378)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: hematoma and impaired healing.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
A female patient who underwent primary breast augmentation using a mentor artoura plus smooth ultra high profile 650cc saline tissue expander on the left and an unknown mentor silicone prosthesis on the right experienced bilateral impaired healing and a hematoma at the left implant site postoperatively.The delayed hematoma on the left side necessitated a surgical evacuation.Following this complication, the patient exhibited continued impaired healing bilaterally, prompting a decision to attempt implant salvage through bilateral replacement with a vancomycin and gentamicin slurry.Subsequently, the patient underwent left-sided replacement with a mentor smhx470 implant (sn (b)(6)) on (b)(6) 2025, to address the complications and optimize healing.This reprt relates to the left side.
Additional Manufacturer Narrative
[adverse event review clinical note and patient coding verification]: coding was reviewed by a clinician on apr-17-2025 per 100553403 and 100553401 with the available information about the reportable event.Added pc ¿ surgical intervention to (b)(6) per event description.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional information received on april 23, 2025, patient right side also replaced with ref# smhx-430, lot#9651502, serial #(b)(6) on (b)(6) 2025.Patient age at the time of the event was updated to '66 years'.Date when the event occurred was updated to december 05, 2024.The report indicated that on march 10, 2025, removed left implant, right side implant remains.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21874365
• Report Number: 1645337-2025-04118
• Device Sequence Number: 15638839
• Product Code: LCJ
• UDI-Device Identifier: 10081317028229
• UDI-Public: (01)10081317028229(11)240503(17)280501(10)9989275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: SDC130UH
• Device Lot Number: 9989275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 04/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White