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

Model Number	SDC110H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent an unspecified breast surgery with an unspecified mentor tissue expander that deflated post implantation.As a result, the patient underwent explantation on an unknown date.
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: tissue expander 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).
Additional Manufacturer Narrative
On 21-mar-2023, mentor received additional information about the event.The following information was reported: the patient¿s race is white and ethnicity is not hispanic/latino.The patient age at the time of event is 41 years old.The event date is 25-jan-2023.The suspect medical device is a mentor artoura plus, smooth, high profile 300cc tissue expander, catalog #sdc110h, lot #9677336, serial #(b)(6), udi #(b)(4), 510(k) #k161176.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.The deflated tissue expander was from the patient¿s left breast.The implantation date is (b)(6) 2022.The explantation date is (b)(6) 2023.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 18-apr-2023, the mentor failure analysis lab received the device for evaluation.On 21-apr-2023, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the tissue expander.Leak testing was performed in accordance with mentor's procedure.Findings revealed three (3) tears on the anterior aspect, all of the tears measuring approximately 0.1 cm.No other leak sites were detected.A microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the three (3) tears.Parallel striations are consistent with markings made by a sharp object perforating the shell of the tissue expander.Based on the information currently available, a microscopic examination of the three (3) tears indicates that the device 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.Capa activity was not required.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: 16585588
• Report Number: 1645337-2023-03270
• Device Sequence Number: 1699996
• 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: 2022
• Device Explanted Year: 2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Model Number: SDC110H
• Device Catalogue Number: SDC110H
• Device Lot Number: 9677336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 04/18/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/31/2023; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White