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

Model Number	3542635
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 54-year-old caucasian female patient underwent a breast augmentation revision surgery with implantation of a 250cc mentor siltex round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant during an in-office visit with a medical professional.As a result, the patient underwent removal on (b)(6) 2023.
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.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.  reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 03, 2023, mentor received the following additional information.Pre-operatively, in addition to the left breast deflation, the patient was diagnosed with right breast implant inferomedial malposition with pseudosymmastia of the medial inframammary fold.As a result, the patient underwent unilateral removal and replacement with a left-sided 300cc mentor smooth round moderate profile saline breast implant and a surgical intervention of the right breast without right-sided removal.Since an additional event was reported, another file was generated to document the contralateral event.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2023-08208 for the contralateral event.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 20, 2023, the mentor analysis lab received the suspect medical device for evaluation.On july 25, 2023, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection and leak testing of the device.Visual analysis of the returned sample revealed that the breast implant had an area of siltex cracking on the posterior view.Leak testing was performed, according to the mentor procedure, and it revealed a tear within the siltex cracking, measuring approximately 0.4 cm.The evaluation determined that the cause of the deflation is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17163457
• Report Number: 1645337-2023-07282
• Device Sequence Number: 5563813
• Product Code: FWM
• UDI-Device Identifier: 00081317001768
• UDI-Public: 00081317001768
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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: 09/30/2018
• Device Model Number: 3542635
• Device Catalogue Number: 3542635
• Device Lot Number: 6861915
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/03/2023; 07/20/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/12/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2014
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White