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

Catalog Number	3503310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 44-year-old caucasian female patient underwent primary breast augmentation with unknown size unknown saline implants smooth and experienced breast implant deflation on her right side postoperatively; diagnosed after physical exam.The patient has consulted with the healthcare professional.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
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 review could be performed.Reason for device explant and/or reoperation: as of now there is no information regarding the explant or reoperation.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.D4: udi: as the lot, and serial number for the device involved in the event was not provided, the full 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 21, 2025, mentor became aware that the date of bilateral replacement surgery is (b)(6) 2025.Mentor also received information regarding the impacted device.Hence, following fields have been updated on this form: is required intervention has been selected under section b; field b2.Field d1 for brand name has been updated to "mentor smooth round high profile".Field d4 for catalog number has been updated to "3503310".Field d4 for unique identifier (udi) has been updated to (b)(4).D4: udi: as the lot, and serial number for the device involved in the event was not provided, the full udi is currently not available.Fields d6b for explantation date is (b)(6) 2025.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 4, 2025, mentor became aware that the replacement device catalog 3503310; serial number (b)(6) will be used on (b)(6) 2025.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 27, 2025, 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).
Additional Manufacturer Narrative
On april 24, 2025, device evaluation was completed as follows: mentor conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.During the visual analysis of the returned device sm hps dv 310cc, a tear was observed at the union between the shell and the valve system.A microscopic examination was performed, and the cause of the deflation could not be identified.Therefore, a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: according to the product insert data sheet, 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.A second product was received.No adverse events were reported for this concomitant (contralateral) device; therefore, no further analysis is required.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20864168
• Report Number: 1645337-2024-14100
• Device Sequence Number: 21040617
• Product Code: FWM
• UDI-Device Identifier: 00081317001638
• UDI-Public: 00081317001638
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 3503310
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 02/04/2025; 03/27/2025; 04/24/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/25/2025; 02/06/2025; 04/21/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White