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

Model Number	3504307M
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a female who underwent an unknown breast surgery with a mentor tissue expander 550cc saline prosthesis experienced defective valve post procedure.The expander has a failure in its valve, not allowing the suction of the air inflated air and consequent insertion of the prosthesis in the submuscular plane.No patient consequences reported, or adverse event reported.
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: defective valve 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
Photo evaluation completed on july 7, 2023 upon visual evaluation of the image provided in the complaint, the tissue expander appears to be inflated.Based on the information currently available, a product issue was identified during the investigation of the photo received.This product issue will be addressed through mentor¿s quality system.Based on the manufacturing investigation the device with the clogged valve reported in the complaint is confirmed to be a manufacturing defect.To raise awareness of this product complaint and to reinforce the current process controls, awareness training was administered and documented.According to the information reported, the expander has a failure in its valve, not allowing the suction of the air-inflated air and consequent insertion of the prosthesis in the submuscular plane.Device evaluation completed on july 11, 2023: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak test of the returned device.During a visual evaluation, no apparent damage or visual anomalies were observed on the exp rnd remote 550cc returned device.Leak testing was performed on the injection reservoir, according to mentor procedure, and it identified that the airflow through the valve into the tissue expander, but the air cannot flow out.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.Per the manufacturing procedure, failure to properly apply the adhesive between the tubing and dome can result in a possible occlusion of the tubing.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 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).

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16690930
• Report Number: 1645337-2023-04044
• Device Sequence Number: 17991367
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2026
• Device Model Number: 3504307M
• Device Catalogue Number: 3504307M
• Device Lot Number: 9708734
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 07/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/05/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Patient Sex: Female