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

Model Number	3504302M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a breast augmentation with a 250 cc mentor tissue expander and experienced a deflation on the left side post-operatively.As a result, the patient underwent explantation on an undisclosed date.
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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 18, 2022, mentor received additional information regarding the patient's information, date of event, device date of implantation, and device date of explantation.The patient's identifier has been updated to (b)(6).The patient's date of birth provided is (b)(6) 2021.The date of event has been updated to (b)(6) 2022.The device date of implantation has been updated to (b)(6) 2022.The device date of explantation has been updated to (b)(6) 2022.On (b)(6) 2022, the mentor failure analysis lab has 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 december 15, 2022, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample revealed that no damage or anomalies were observed on the exp rect remote 250cc tissue expander leak testing was performed, according to the mentor procedure, and it identified a tear at the union between the shell and the patch on the posterior view.In addition, no other leak sites were detected.A microscopic examination was performed, and the cause of the tear could not be identified.Therefore, a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.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.According to the manufacturing investigation, with consideration of process controls and manufacturing records the complaint could not be confirmed as a manufacturing defect.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15439914
• Report Number: 1645337-2022-10932
• Device Sequence Number: 17647352
• Product Code: LCJ
• UDI-Device Identifier: 00081317002383
• UDI-Public: 00081317002383
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K842883
• 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: Foreign,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: 02/14/2026
• Device Model Number: 3504302M
• Device Catalogue Number: 3504302M
• Device Lot Number: 9686634
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/18/2022; 12/15/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/11/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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 Sex: Female