MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS SMOOTH; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	UNK_SALINE IMPLANTS SMOOTH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
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.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).
Event or Problem Description
It was reported that a patient underwent a breast augmentation primary with unspecified mentor saline breast implants and experienced bilateral deflation post-operatively, which was confirmed during a physical exam.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the first of two devices.
Additional Manufacturer Narrative
On nov 1, 2024, additional information was received indicating the patient underwent removal and replacement with mentor saline devices on aug 20, 2024.The patient also reportedly experienced capsular contracture baker grade ii on the left side.The impacted products were identified as mentor smooth round spectrum 225cc breast implants, catalog number 3501430.This report is for the right breast prosthesis.D4: udi: as the lot/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 dec 1, 2024, the mentor failure analysis lab received the device for evaluation.The impacted products were identified as unknown saline implants smooth.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak test, microscopic examination, and thickness measurement of the returned device.During visual analysis of the returned sample, no apparent damage or visual anomalies were observed.Leak testing was performed, in accordance with mentor's procedures.Findings revealed a tear at the juncture of the valve system.A microscopic examination was performed, and the cause of the tear 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANTS SMOOTH
• 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: 19553723
• Report Number: 1645337-2024-07286
• Device Sequence Number: 14665174
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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 Catalogue Number: UNK_SALINE IMPLANTS SMOOTH
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 12/01/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/23/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White