MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501625
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of an undisclosed mentor saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right breast implant during a physical exam with a medical professional.As a result, the patient was scheduled for breast implant removal on (b)(6) 2025.
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.Since no lot number was provided, no manufacturing record evaluation could be performed.D4: udi: as all 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: deflation.Date of explantation: (b)(6) 2025.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 04, 2025, the mentor analysis lab received the suspect medical device for evaluation.With the returned device, the product identity was determined as the following: size: 200cc.Brand name: mentor smooth round moderate profile.Catalog: 3501625.Lot: 7414558.Paperwork received with the device provided an updated explantation date.Date of explantation: (b)(6) 2025.On june 30, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection, leak test, and microscopic examination of the device.During visual analysis of the returned device no apparent damage or visual anomalies were observed.Leak testing was performed in accordance with mentor's procedures.Findings revealed a leak from the valve.Also, a tear was found within a crease/fold on the posterior view, measuring approximately 0.1 cm.Microscopic examination was performed, and the cause of the valve leakage could not be determined.Although no conclusion could be reached on the cause of valve leakage in the reported event, the instructions for use contain the following caution: the valve system can be damaged by improper use of the fill-tube stylet.Care should be taken that the stylet enters the valve smoothly.Use the thumb and forefinger to stabilize/support the valve seat and gently push the stylet tip into the valve opening.Overstressing the valve material may result in punctures or tears and subsequent deflation may occur.Use only the fill tube stylet provided with this product.Take care not to puncture the diaphragm valve or the shell with the stylet tip.Care must also be taken when the fill tube stylet is removed to prevent damage to the valve assembly.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 21936123
• Report Number: 1645337-2025-04634
• Device Sequence Number: 17450151
• Product Code: FWM
• UDI-Device Identifier: 00081317001201
• UDI-Public: 00081317001201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 01/08/2021
• Device Catalogue Number: 3501625
• Device Lot Number: 7414558
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2017
• 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: 51 YR
• Patient Sex: Female