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

Catalog Number	3549113
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast surgery with implantation of a 450cc mentor cpx 4 breast tissue expander with suture tabs.Post-operatively, both expanders had leaked twice, and ultimately, the expanders deflated requiring a refilling with saline solution.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Several follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional 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.Since no lot number was provided, no manufacturing record evaluation could be performed.D4: udi: as most of the device characteristics are unknown at this time, the udi is currently not available.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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 21, mentor became aware that information was inadvertently omitted from the initial report or incorrectly reported.Corrected data: a2 patient age at the time of event: 42 years old.B2 is required intervention: checkbox should have been marked.B3 date of event: april 29, 2025.B5 event description: the patient was implanted during a primary breast reconstruction surgery.D4 lot: 9912103.D4 expiration date: may 20, 2027.D6a date of implantation: (b)(6) 2024.D6b date of explantation: (b)(6) 2025.H4 device manufacture date: may 25, 2023.H6 health effect - impact code: device explantation (f1903).H6 type of investigation: device not received (b17).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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 19, 2025, 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.A patient identifier was also provided.Patient identifier: c.E.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 22, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted a visual inspection, leak testing, and microscopic examination of the tissue expander.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, in accordance with mentor procedures, a tear on the anterior view measuring 0.3 cm located at 5 o'clock position was observed on the juncture between the shell and bladder.Microscopic examination was performed and the cause of the tear could not be identified.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.The collected process controls and data records for the deflated tissue expander meet specifications.The tear mentioned cannot be conclusively confirmed as a manufacturing defect.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: the silicone shell of the tissue expander may easily be cut by a scalpel or ruptured by excessive stress, manipulation with blunt instruments, or penetration by a needle.Subsequent deflation and/or rupture could result.All devices should be carefully inspected for structural integrity prior to and during implantation.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 22064816
• Report Number: 1645337-2025-05633
• Device Sequence Number: 7849528
• Product Code: LCJ
• UDI-Device Identifier: 00081317006671
• UDI-Public: 00081317006671
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Catalogue Number: 3549113
• Device Lot Number: 9912103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 11/19/2025; 02/22/2026
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 05/23/2025; 12/18/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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: Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female