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

Catalog Number	SCPX117MH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/31/2023
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.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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 66-year-old asian female patient underwent a breast surgery with a 350cc mentor cpx 4 breast tissue expander.Post-operatively, the patient experienced a deflation of her left prosthesis, which was confirmed during a physical exam.As a result, the patient underwent removal surgery on (b)(6) 2023.
Additional Manufacturer Narrative
On august 10, 2023, mentor 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 september 25, 2023, mentor completed a visual inspection and leak testing of the returned device.Device evaluation summary: during the visual evaluation, was identified a delamination area at the juncture of the injection dome and bladder of the returned device.Leak testing was performed, in accordance with mentor procedures and observed leakage in the delamination at the juncture of the injection dome and bladder.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 the mentor¿s quality system.According to the manufacturing investigation, fourier transform infrared spectroscopy (ftir) was performed to evaluate if poly sheeting presence was contributing to the root cause of the delamination in the injection dome assembly of the returned devices, as a result of the analysis no poly sheeting was found.In conclusion, with consideration to the process controls, the evaluation performed by the complaint handling team, data records reviewed and the fourier transform infrared spectroscopy (ftir) for the complaint device, the delamination reported on the product complaints is not able to be confirmed as manufacturing defect.The cause of the delamination could not be confirmed.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST 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: 17454862
• Report Number: 1645337-2023-09102
• Device Sequence Number: 7347948
• Product Code: LCJ
• UDI-Device Identifier: 10081317028366
• UDI-Public: 10081317028366
• 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: 2022
• Device Explanted Year: 2023
• 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: 06/07/2026
• Device Catalogue Number: SCPX117MH
• Device Lot Number: 9735045
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 09/25/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/29/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian