MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	TEXP155RH
Medical Device Problem Codes	Material Rupture (1546); Use of Device Problem (1670); Defective Device (2588)
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.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.Reason for device explant and/or reoperation: defective device.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision with an artoura breast tissue expander 850cc which was reportedly defective during expansion.No specific failure mode was provided.As a result, the patient underwent removal on (b)(6) 2023.
Additional Manufacturer Narrative
On jun 23, 2023, the mentor failure analysis lab 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.Per the ifu, the impacted product is not intended for use beyond six months.Since this device was implanted longer than six months, h6.Medical device problem code a23 (use of device problem) has been added.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After secondary review performed on (b)(6)2023, h6.Medical device problem code has been updated from a0203 (defective device) to a0412 (material rupture).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned tissue expander.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the artoura hp breast te 850cc tissue expander.Leak testing was performed, in accordance with mentor procedures.Findings revealed two tears, tear b at the union between the bladder and injection dome, and tear a on the anterior aspect measuring approximately 0.9 cm.A microscopic examination was performed, and the cause of tear b could not be identified.In addition, a microscopic examination of tear a indicates that the tissue expander could have been damaged during or subsequent to implantation.The product insert data sheet cautions not to 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.According to the date of implantation and explantation, it was noticed that the device remained implanted for more than 6 months.Per mentor instructions for use (ifu), tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off-label manner.Per manufacturing procedures, all devices are leak-tested and inspected for defects.The compliant device presents two tears not in any of the device's vulcanized joints.Upon microscopic examination, the cause of tear a points to potential damage during or subsequent to implantation, with an undetermined cause for tear b.Therefore, the complaint cannot be confirmed to be a manufacturing defect.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• 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: 17012207
• Report Number: 1645337-2023-06095
• Device Sequence Number: 20590951
• Product Code: LCJ
• UDI-Device Identifier: 00081317009511
• UDI-Public: 00081317009511
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150777
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 03/10/2025
• Device Model Number: TEXP155RH
• Device Catalogue Number: TEXP155RH
• Device Lot Number: 9543695
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 08/29/2023; 09/25/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/14/2023; 09/18/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2021
• 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