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

Catalog Number	3549213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 71-year-old caucasian female patient underwent breast surgery with 450cc mentor cpx 4 breast tissue expander with suture tabs and experienced expander deflation on her right side postoperatively; diagnosed in the office.The patient has consulted with the healthcare professional.As a result, the patient underwent removal only surgery on (b)(6) 2023.It was reported that patient's condition improved after the surgery.
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: right 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).
Additional Manufacturer Narrative
On december 21, 2023, the evaluation for the device was completed.Device evaluation summary: during the visual evaluation of the med height te w/sut tabs 450cc tissue expander, the tear was not identified.As a result, leak testing was performed in accordance with mentor procedures, and a tear was identified at the suture tab 6 o¿clock position.When evaluated under a microscope the tear pattern did not reveal parallel striations that are consistent with markings made by a sharp instrument.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through mentor¿s quality system.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on the manufacturing investigation, there were no abnormalities with the manufacturing of the tissue expander that would have impacted its performance.Therefore, with consideration of the process controls, the evaluation performed, and the data records reviewed on the complaint device, the deflation reported on this product is not able to be confirmed as a manufacturing defect.We would like to assure you that mentor adheres to the highest standards of quality.Our quality assurance process is robust for every product we make and requires that each mentor product undergoes a stringent visual inspection and rigorous testing prior to shipment.In addition, we maintain a comprehensive quality assurance system that complies with the food and drug administration's (fda) good manufacturing practice regulations.Prior to shipping, our devices are checked to ensure that they satisfy these standards in accordance with these processes.We also closely and continually monitor and review the clinical performance and real-world evidence for all our products through clinical studies, registries, and post-market surveillance activities.Potential cause while deflation is historically the most common complication related to tissue expanders, the rate of deflation with mentor® tissue expanders remains very low.An incident of this nature may be the result of one or more of the following factors: overinflating of the tissue expander, use of the tissue expander in emerging surgical techniques not identified in the instructions for use (ifu), continuous and sustained stresses to the tissue expander, vigorous body movement (e.G.Physical exercise) or excessive manipulation/ trauma in the region of the expander.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 12, 2023, the mentor failure analysis lab 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).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• 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: 17661956
• Report Number: 1645337-2023-10276
• Device Sequence Number: 17914183
• Product Code: LCJ
• UDI-Device Identifier: 00081317006732
• UDI-Public: 00081317006732
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130813
• 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: Health Professional
• 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: 09/19/2025
• Device Catalogue Number: 3549213
• Device Lot Number: 9629704
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 12/21/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/26/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White