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

Catalog Number	3542670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent breast augmentation revision with two 425cc mentor siltex round moderate profile saline breast prostheses.Post-operatively, the patient suffered right breast implant deflation.As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2024.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, the patient experienced a deflation in the breast implant.The deflated breast implant involved in this complaint was not received.Therefore, your device couldn´t be analyzed according to our procedures.Please ship the product back to receive a more detailed analysis about your product complaint.  if you have recently shipped the product back, please provide your tracking numbers by replying to this email.If you need additional support to return the deflated device, please contact our team using the information contained at the end of this letter.Although the product was not received, the manufacturing records of the lot-serial number were reviewed.The manufacturing standards were met prior to the release of this lot.  each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Deflation complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Device history lot null.Device history batch null.Device history review : a manufacturing record evaluation was performed for the finished device 222619 number, and no non-conformances were identified.Manufacturing date: jan 2001 expiration date: jan 2005.
Additional Manufacturer Narrative
On october 14, 2024, the mentor failure analysis lab received the device for evaluation.On october 17, 2024, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the sal siltex rnd diap pkg 425cc breast implant was found to have a tear on the posterior view, measuring approximately 0.5 cm.Leak testing was performed, in accordance with mentor procedures, and no additional leak sites were detected during the analysis.Microscopic examination was performed and the cause of the deflation could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.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 to approved specifications.No corrective and preventive action (capa) is required now.
Additional Manufacturer Narrative
On september 3, 2024, mentor received additional information indicating that the patient's date of explantation was updated to (b)(6) 2024.Mentor also became aware that section 11.Additional manufacturer narrative of the initial report contained inaccurate information.The following are the correct information: 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.Reason for device explant and/or reoperation: material rupture.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).

• 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: 19716311
• Report Number: 1645337-2024-08228
• Device Sequence Number: 8290164
• Product Code: FWM
• UDI-Device Identifier: 00081317001829
• UDI-Public: 00081317001829
• 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: 2005
• 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 Expiration Date: 01/31/2005
• Device Catalogue Number: 3542670
• Device Lot Number: 222619
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 10/14/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2001
• 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: 64 YR
• Patient Sex: Female