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

Catalog Number	SDC135UH
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent primary breast reconstruction with a 700cc mentor artoura plus, smooth, ultra high-profile tissue expander experienced an unspecified device issue on the left side post procedure.The device was stated to have failed.As a result, explant and replacement with mentor gel was performed on (b)(6) 2024.
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: unknown device failure.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).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on october 23, 2024.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the tissue expander.Visual analysis of the returned sample revealed that the tissue expander was found to have a tear at the junction between the shell and bladder at the three o'clock position.Microscopic examination was performed, and the cause of the deflation could not be identified.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.According to the manufacturing investigation and with consideration of the process controls, the evaluation performed, and the data records reviewed, the issue cannot be confirmed as a manufacturing defect.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20249736
• Report Number: 1645337-2024-10889
• Device Sequence Number: 7313027
• Product Code: LCJ
• UDI-Device Identifier: 10081317028236
• UDI-Public: (01)10081317028236(17)271015(10)9979310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SDC135UH
• Device Lot Number: 9979310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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: 39 YR
• Patient Sex: Female