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

Catalog Number	3544507
Medical Device Problem Codes	Material Rupture (1546); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 58-year-old caucasian female patient underwent a primary breast augmentation with 450cc mentor memorygel breast implant and experienced a rupture on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2023, and was replaced with a mentor gel breast prosthesis.
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: 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).
Additional Manufacturer Narrative
On january 23, 2024, the mentor failure analysis lab has received two devices for evaluation.It is unknown which device pertains to the complaint.On january 24, 2024, the evaluation for the devices were completed.Both evaluation summaries were identical.Devices evaluation summary: visual analysis of the returned sample revealed that no damage or anomalies were observed on the gel siltex mod-rnd 450cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture status identified by mri evaluation includes both suspected ruptures, which are those ruptures identified by mri but not confirmed by explantation and examination of the device, and confirmed ruptures, which are those ruptures that are confirmed by evaluation of the explanted devices.The event described could not be confirmed as the breast implant was returned without detectable gel exposure.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.Manufacturer¿s reference number: (b)(4) in the previous report, mentor erroneously omitted the receipt of the device/s in section h10.This information has been added to this report.On january 23, 2024, the mentor failure analysis lab has received two devices for evaluation.It is unknown which device pertains to the complaint.
Additional Manufacturer Narrative
On january 25, 2024, mentor received additional information regarding the impacted device.It was reported that the impacted device was a 450cc mentor memorygel breast implant with lot number 209655.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.On february 12, 2024, mentor then determined that this complaint is a duplicate complaint.Please see reference manufacturer's report number 1645337-2019-15405 and 1645337-2019-15406 for documentation on this event.All further regulatory reporting will be submitted in manufacturer's report number 1645337-2019-15405 and 1645337-2019-15406.Section h6-medical device problem code a27: no product quality issue.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: 18576514
• Report Number: 1645337-2024-00935
• Device Sequence Number: 7708715
• Product Code: FTR
• UDI-Device Identifier: 00081317000723
• UDI-Public: 00081317000723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• 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: 04/30/2005
• Device Catalogue Number: 3544507
• Device Lot Number: 209655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 01/24/2024; 01/25/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 01/24/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2000
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White