MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 PLUS, SMOOTH, LOW HEIGHT; EXPANDER, SKIN, INFLATABLE

Catalog Number	SCPX157LH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/25/2024
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: 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).
Event or Problem Description
It was reported that a 37-year-old female patient underwent a breast surgery with 650cc mentor cpx4 plus, smooth, low height tissue expander and experienced a deflation on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2024, and replaced with another tissue expander.
Additional Manufacturer Narrative
On february 26, 2024, 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 may 31, 2024, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample revealed that the cpx4 plus sm te lh 650cc tissue expander had a tear between the bladder and shell.Microscopic examination was performed and the cause of the deflation 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 notification was sent to mentor's manufacturing team for further investigation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the issue reported were identified.After a review of the process controls, data records, and visual analysis of the device, the cause of the observed tear could not be confirmed as manufacturing-related.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.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 CPX4 PLUS, SMOOTH, LOW HEIGHT
• 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: 18705180
• Report Number: 1645337-2024-01764
• Device Sequence Number: 12159422
• Product Code: LCJ
• UDI-Device Identifier: 10081317028335
• UDI-Public: 10081317028335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 01/27/2025
• Device Catalogue Number: SCPX157LH
• Device Lot Number: 9528916
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 05/31/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/18/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female