MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Model Number 3549215

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problems Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  Injury  

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 Description

It was reported that a 28-year-old female who underwent breast reconstruction with 650cc mentor cpx 4 breast tissue expander with suture tabs experienced bilateral deflation post procedure.The seam on the lower border of the implant was ruptured.As a result, explant was performed on (b)(6) 2021.See 1645337-2023-02242 for contralateral prosthesis report.

Manufacturer Narrative

Additional information was received on april 27, 2023.The device issue, originally reported as bilateral deflation, was only unilateral.Confirmation was received that the device pertaining to this manufacturer report number had not adverse event or product issue associated with it.Therefore, no further reporting will be performed on this device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Type of Device: 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: 16455235
• MDR Text Key: 310375887
• Report Number: 1645337-2023-02240
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317006756
• UDI-Public: 00081317006756
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Model Number: 3549215
• Device Catalogue Number: 3549215
• Device Lot Number: 9411963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female