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

Model Number	SDC120UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/18/2022
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: material rupture.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 66-year old female patient underwent breast prosthesis implantation surgery with a 535cc mentor artoura plus, smooth, ultra high profile on the right breast and suffered breast implant deflation, post-operatively.As a result, the patient underwent breast implant removal surgery on (b)(6) 2022.
Additional Manufacturer Narrative
On (b)(6) 2022, mentor received additional information indicating that the patient's implant was replaced with a 535cc mentor artoura plus, smooth, ultra high profile (catalog: sdc120uh lot: 9703512 sn: (b)(6) on november 9, 2022.
Additional Manufacturer Narrative
On december 13, 2022, 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.
Additional Manufacturer Narrative
On february 9, 2023, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection, leak testing and microscopic examination of the returned device.During the visual analysis of the returned sample artoura plus sm te uhp 535cc, no apparent damage or visual anomalies were observed.Leak testing was performed in accordance with mentor's procedure.Findings revealed a tear at the union between the shell and the patch, on the anterior view.Additionally, no other leak sites were detected.Microscopic examination was performed, and the cause of the tear could not be identified.As the authorization form for examination was not received the evaluation was limited to non-destructive testing; therefore, the shell thickness was not measured.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Manufacturing investigation was performed, the process controls and data records collected are within specification.For the tear in the seam reported for the lot number, this complaint is not able to be confirmed as a manufacturing defect.An analysis of the suspect medical device's photo was also completed.Summary: upon visual evaluation of the images provided in the complaint, the tissue expander was observed deflated.Based on the information currently available, a product issue was identified during the investigation of the photos received.This product issue will be addressed through mentor¿s quality system.

• 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: 15844877
• Report Number: 1645337-2022-14146
• Device Sequence Number: 20567910
• Product Code: LCJ
• UDI-Device Identifier: 10081317028212
• UDI-Public: 10081317028212
• 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: 2022
• Device Explanted Year: 2022
• 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: 01/21/2026
• Device Model Number: SDC120UH
• Device Catalogue Number: SDC120UH
• Device Lot Number: 9670360
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 12/13/2022; 02/09/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/09/2022; 01/04/2023; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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: 66 YR
• Patient Sex: Female