MAUDE Adverse Event Report: MENTOR TEXAS MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Catalog Number SDC130UH

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

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

Event Type  Injury  

Event Description

It was reported that a female patient underwent breast surgery with a 650cc mentor artoura plus, smooth, ultra high profile and experienced another spontaneous deflation to her replacement tissue expander and needed another surgery.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: as of now there is no information regarding the explant or reoperation.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).

Manufacturer Narrative

On april 4, 2024, mentor became aware that the date of bilateral replacement with placement of permanent 480cc memory gel boost implants was march 27, 2024.Hence, following fields have been updated on this form: is required intervention has been selected under section b; field b2.Fields d6b for explantation date have been updated to (b)(6), 2024.Field h6 health effect - impact code ¿device explantation¿ has been added.Field h6 type of investigation has been updated to "device not returned".Reason for device explant and/or reoperation: right deflation 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.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On april 19, 2024, mentor became aware that this mentor manufacturer's report number is a duplicate of mentor manufacturer's report number 1645337-2024-04699.Hence, any additional information will be reported under the manufacturer's report number 1645337-2024-04699.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE
• 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: 19033777
• MDR Text Key: 339263202
• Report Number: 1645337-2024-04067
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10081317028229
• UDI-Public: 10081317028229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SDC130UH
• Device Lot Number: 9875521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2023
• 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): Other; Required Intervention
• Patient Sex: Female