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

Catalog Number	3504307M
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast reconstruction procedure with a mentor tissue expander 550cc device that could not be filled through the port.As a result, the device was explanted and it was replaced with another mentor tissue expander 550cc device on 10-jul-2023.
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.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: inability to fill device.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: pc(b)(4).
Additional Manufacturer Narrative
On 06-oct-2023, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the tissue expander could not be filled through the port during the procedure.The product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.During visual analysis of the returned sample, the tissue expander no apparent damage or visual anomalies were observed.Leak testing was performed, in accordance with mentor procedures and the air flowed through the tubing as expected but a tear was identified in the union of the shell and the patch.Microscopic examination was performed and the cause of the tear could not be identified.Thickness measurement was not performed to avoid compromising the device integrity.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.According to the manufacturing investigation, the device was inspected for defects, delamination, joint elongation and for leaks, and was manufactured following normal process, the cause of the tear could not be determined.Additionally, the event reported in this product complaint could not be confirmed as a manufacturing defect.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).

• 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: 17504731
• Report Number: 1645337-2023-09394
• Device Sequence Number: 6217342
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K842883
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: 3504307M
• Device Lot Number: 9816439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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: Unknown