MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3507150MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent breast augmentation procedure with a 190cc mentor memorygel breast implant and experienced capsular contracture; baker grade iii on her left side postoperatively.As a result, the device was explanted on an unknown date.
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture 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.Since no malfunction was observed during the investigation, 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.Reason for device explant and/or reoperation: left capsular contracture; baker grade iii 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per information received, the following fields have been updated on this form: - patient's initials have been updated to "(b)(6)".- procedure performed was revision breast augmentation.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 february 20, 2024, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sm mod classic gel, 150cc breast implant was found to have some bubbles within the gel.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture 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).
Additional Manufacturer Narrative
On february 7, 2024, mentor became aware regarding the device information.Hence, the following fields have been updated on this form: - field d1 for brand name has been updated to "mentor memorygel breast implant" - field d4 for catalog number has been updated to "3507150mc" - field d4 for lot number has been updated to "9719720" - field d4 for serial number is (b)(6) - field d4 for unique identifier( udi) has been updated to (b)(4).- field d6b have been updated to (b)(6) 2023.Replacement device used was catalog number 3507190mc; serial number (b)(6).A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.On february 8, 2024, 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).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 18342192
• Report Number: 1645337-2023-14782
• Device Sequence Number: 8424691
• Product Code: FTR
• UDI-Device Identifier: 00081317004073
• UDI-Public: 00081317004073
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3507150MC
• Device Lot Number: 9719720
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 02/08/2024; 02/20/2024
• Initial Report FDA Received Date: 12/17/2023
• Supplement Report FDA Received Date: 02/13/2024; 02/19/2024; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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 Sex: Female