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

Catalog Number	3544500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Deformity/ Disfigurement (2360); Wrinkling (2613)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent revision breast augmentation with 500cc mentor memorygel breast implant and experienced breast implant rupture on her right side postoperatively; diagnosed via mri scan.The patient has consulted with the healthcare professional.As a result, the device will be explanted 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.Reason for device explant and/or reoperation: right rupture.D6b explantation date: (b)(6) 2023.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 october 20, 2023, mentor became aware that the patient also experienced right side granuloma, and bilateral cutaneous contour deformity in addition to right side rupture and underwent bilateral explantation and replacement surgery with catalog number smhx500; serial number (b)(6) on the left side, and with catalog number smhx500; serial number (b)(6) on the right side on (b)(6) 2023.Coding under section h has been updated accordingly on this form.Reason for device explant and/or reoperation: right rupture, granuloma, and cutaneous contour deformity.This supplemental medwatch report is for the patient¿s right-sided device.Left side complication is being reported separately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 3, 2023, mentor became aware that the patient's age at the time of event was 57.Hence, field a2 has been updated accordingly.On november 7, 2023, the mentor failure analysis lab received the device for evaluation.On november 8, 2023, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the siltex hpg, 500cc 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 1.2 cm.A microscopic examination was performed, and instrument damage was not found at the edges of the tear.The evaluation determined that the possible cause of the rupture was 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.Granulomas are noncancerous nodules that are a common tissue reaction to the presence of a variety of foreign materials, such as silicone.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 will be conducted through complaint trending as part of post-market surveillance.This supplemental medwatch report is for the patient¿s right-sided device.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: 17885786
• Report Number: 1645337-2023-11486
• Device Sequence Number: 15276134
• Product Code: FTR
• UDI-Device Identifier: 00081317001119
• UDI-Public: 00081317001119
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 02/12/2022
• Device Catalogue Number: 3544500
• Device Lot Number: 7431470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 11/03/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/02/2023; 11/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• 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: 57 YR
• Patient Sex: Female