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

Catalog Number	3507425MC
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/22/2024
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: breast prosthesis rupture.D6b explantation month, day, and year: (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 patient underwent a breast augmentation revision procedure with a mentor memorygel breast implant 425cc gel breast prostheses that both ruptured post implantation.Bilateral rupture was diagnosed via ultrasound.As a result, the patient is scheduled to undergo bilateral explantation on (b)(6) 2024.This medwatch report is for the patient¿s right breast prosthesis.
Additional Manufacturer Narrative
On 10-jun-2024, mentor received additional information about the event.The patient decided to postpone the explantation surgery scheduled for (b)(6) 2024.An updated explantation date was not provided.Manufacturer¿s reference number:(b)(4).
Additional Manufacturer Narrative
On 18-sep-2024, mentor received additional information about the event: - the patient underwent bilateral explantation and replacement with a mentor memorygel breast implant 425cc gel breast prosthesis and a mentor memorygel breast implant 405cc gel breast prosthesis on (b)(6) 2024.- during explant surgery, both removed breast prostheses were noted to be intact.The removed left breast prosthesis had two folds on it.Block b1 ¿is product problem¿ no longer applies to this report nor does h6 medical device problem code material rupture (a0412).Reason for device explant and/or reoperation: ultrasound diagnosed breast prosthesis rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02-oct-2024, the mentor failure analysis lab received the device for evaluation.On 08-oct-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according with the information received, the breast prosthesis was suspected to have ruptured.During explant surgery, it was discovered to be intact.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 breast implant was found to have multiples punctures on the anterior view measuring approximately 0.1 cm.Leak testing was performed, in accordance with mentor procedures, and no other areas of gel exposure were detected during the analysis.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the punctures.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, the microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.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 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: 18881356
• Report Number: 1645337-2024-02984
• Device Sequence Number: 21146115
• Product Code: FTR
• UDI-Device Identifier: 00081317004202
• UDI-Public: (01)00081317004202(17)160531(10)6475654(21)6475654-043
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,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: 05/31/2016
• Device Catalogue Number: 3507425MC
• Device Lot Number: 6475654
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 09/18/2024; 10/02/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/24/2024; 09/23/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2011
• 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: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White