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

Catalog Number	3502650
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/03/2024
Type of Reportable Event	Serious Injury
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.Reason for device explant and/or reoperation: rupture.Section d6b.Explantation date: (b)(6) 2024.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).
Event or Problem Description
It was reported that a 59-year-old caucasian female patient underwent a breast augmentation revision with two 480cc mentor memorygel breast implants and experienced bilateral ruptures post-operatively, which was diagnosed with an ultrasound and physical exam.As a result, the patient is to undergo explantation on (b)(6) 2024.This report is for the right-side device.
Additional Manufacturer Narrative
On october 14, 2024, mentor received additional information reporting that the patient was to undergo device explantation on (b)(6) 2024.It was also reported that the healthcare provider initially provided the incorrect impacted device information.The correct impacted device was updated to 650cc mentor smooth round moderate plus profile saline breast prosthesis (catalog number: 3502650).The lot number was updated to 9522779.The serial number was updated to (b)(6).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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 25, 2024, the mentor failure analysis lab has received the device for evaluation.On november 27, 2024, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample, determined that the sm mpps dv 650cc breast implant was found to be deflated.An area of material separate from the device was found on the posterior view, measuring approximately 9.0 cm x 5.1 cm.Microscopic examination was performed on the edges of the tear, and parallel striations were found in an area of the area of separate material), measuring approximately 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause in the remaining area of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.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 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 MODERATE PLUS 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: 20304672
• Report Number: 1645337-2024-11199
• Device Sequence Number: 12698878
• Product Code: FWM
• UDI-Device Identifier: 00081317001508
• UDI-Public: (01)00081317001508(17)241124(10)9522779
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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: 11/24/2024
• Device Catalogue Number: 3502650
• Device Lot Number: 9522779
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/25/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/24/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White