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

Model Number	SDC150H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 750cc mentor artoura plus, smooth, high profile breast tissue expander.Post-operatively, the patient experienced a deflation of her right prosthesis, which was confirmed by a medical professional.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Several follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On may 29, 2023, mentor received additional information.Patient ethnicity was added as hispanic/latino.Patient race was added as white.Patient's age was updated to 29.Date of event was updated to (b)(6) 23.Mentor became aware that the patient was implanted during a breast reconstruction surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 30, 2023, mentor received additional information.Patient identifier and date of birth were updated.Date of event was updated to 4/19/2023.Mentor became aware that the patient underwent removal surgery on (b)(6) 2023.Reason for device explant and/or reoperation: deflation.On december 12, 2023, mentor evaluated a photo of the explanted device.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the tissue expander appears deflated.On december 13, 2023, mentor 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 21, 2024, mentor completed a visual inspection and material evaluation of the returned tissue expander.Device evaluation summary: visual analysis of the returned sample revealed a leakage, caused by the delamination between the bladder and the injection dome on the tissue expander.Based on the current information, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.Fourier transform infrared spectroscopy (ftir) was performed and results revealed that poly sheeting material (polyethylene) is not found in the device only polydimethylsiloxane base material is observed.With consideration of the process controls, the evaluation performed, and the data records reviewed on the complaint device, the delamination reported on this product cannot be confirmed as a manufacturing defect.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 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: 16994394
• Report Number: 1645337-2023-06118
• Device Sequence Number: 11626764
• Product Code: LCJ
• UDI-Device Identifier: 10081317028274
• UDI-Public: 10081317028274
• 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: 2023
• 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,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: 04/04/2025
• Device Model Number: SDC150H
• Device Catalogue Number: SDC150H
• Device Lot Number: 9559179
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 05/29/2023; 11/30/2023; 02/21/2024
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/15/2023; 12/19/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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: Other; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White