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

Catalog Number	SDC135UH
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: deflation.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient who underwent breast reconstruction with 700cc mentor artoura plus smooth ultra high-profile tissue expanders experienced bilateral deflation post procedure.As a result, explant was performed on (b)(6) 2025.
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on june 2, 2025.The investigation of the returned device was completed by the failure analysis lab on june 9, 2025.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.During visual analysis of the returned device no apparent damage or visual anomalies were observed.Leak testing was performed, according to mentor procedures, and it identified multiple punctures outside of the palpation ring.Microscopic examination was performed on the edges of the puncture found, and parallel striations were found in the whole area of the punctures.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, microscopic examination of the returned product indicates that the tissue 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.According to the instructions for use (ifu), surgeons should ensure the position of the fill dome prior to adding or withdrawing fluid.Needle punctures on or outside the palpation ring of the device may penetrate the shell causing deflation or compromise the fill dome.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: 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).
Additional Manufacturer Narrative
The investigation of the returned device was updated by the failure analysis lab on july 29, 2025.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.During visual analysis of the returned device no apparent damage or visual anomalies were observed.Leak testing was performed according to mentor procedures and it identified multiple punctures outside of the palpation ring.Microscopic examination was performed on the edges of the puncture found, and parallel striations were found in the whole area of the punctures.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, microscopic examination of the returned product indicates that the tissue 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.According to the instructions for use (ifu), surgeons should ensure the position of the fill dome prior to adding or withdrawing fluid.Needle punctures on or outside the palpation ring of the device may penetrate the shell causing deflation or compromise the fill dome.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: 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, 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 ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 22074267
• Report Number: 1645337-2025-05696
• Device Sequence Number: 13102065
• Product Code: LCJ
• UDI-Device Identifier: 10081317028236
• UDI-Public: 10081317028236
• 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 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• Device Catalogue Number: SDC135UH
• Device Lot Number: 9538186
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 07/29/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/16/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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