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

Model Number	SDC130UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/12/2023
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.Since no lot number was provided, no manufacturing record evaluation could be performed.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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with implantation of an undisclosed mentor breast tissue expander prosthesis.Post-operatively, the patient was diagnosed with a ruptured right breast expander by a medical professional.As a result, the patient underwent removal and replacement with an undisclosed prosthesis on (b)(6) 2023.The date of implantation and event were not provided to mentor.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On june 06, 2023, mentor received the following additional information: age: 51 ethnicity: not hispanic/latino race: white date of event: may 12, 2023 date of implantation: (b)(6) 2023 complaint device information: size: 650cc brand name: mentor artoura plus, smooth, ultra high profile catalog: sdc130uh lot: 9810797-002 serial: (b)(6).With the provided lot, a manufacturing record evaluation (mre) was performed on 9810797, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 30, 2023, the mentor analysis lab received the suspect medical device for evaluation.On july 04, 2023, mentor completed an evaluation on the returned device.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the device.During visual analysis of the breast implant device, no apparent damage or visual anomalies were observed.Leak testing was performed, in accordance with mentor procedures, and it identified a tear on the anterior view, measuring approximately 0.1 cm.In addition, no other tears were detected during the analysis.A microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, a microscopic examination of the returned product indicates that the tissue expander could have being 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.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: 17071412
• Report Number: 1645337-2023-06623
• Device Sequence Number: 5885895
• Product Code: LCJ
• UDI-Device Identifier: 10081317028229
• UDI-Public: 10081317028229
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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

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: 10/05/2026
• Device Model Number: SDC130UH
• Device Catalogue Number: SDC130UH
• Device Lot Number: 9810797
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 06/30/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White