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

Catalog Number	SDC110H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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: left deflation.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
It was reported that a female patient underwent breast surgery with a 300cc mentor artoura plus, smooth, high profile and experienced breast implant deflation on her left side.Follow-up will be performed to understand when the aspiration that led to deflation was done.Supplemental report will be submitted upon receipt of information.The patient underwent left side replacement surgery with catalog number smpb290; serial number (b)(6) on (b)(6) 2024.
Additional Manufacturer Narrative
On april 4, 2024, the mentor failure analysis lab received the expander for evaluation.On april 12, 2024, expander evaluation was completed as follows: mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.During the visual analysis of the returned sample artoura plus sm te hp 300cc, no apparent damage or visual anomalies were observed.Leak testing was performed, according to the mentor procedure, and it revealed two (2) tears (a&b) on the anterior view, measuring approximately 0.1 cm and 0.3 cm respectively.No other leak sites were found.Microscopic examination was performed on the edges of the ruptures (a&b), and parallel striations were found in the whole area of both tears.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, the microscopic examination of the returned product indicates that the expander could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.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, 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: 18748699
• Report Number: 1645337-2024-01716
• Device Sequence Number: 14384979
• Product Code: LCJ
• UDI-Device Identifier: 10081317028175
• UDI-Public: 10081317028175
• Combination Product (Y/N): N
• 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: Company Representative
• 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: SDC110H
• Device Lot Number: 9959190
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 Sex: Female