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

Catalog Number	3541458G
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 review could be performed.Reason for device explant and/or reoperation: n/a 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 who underwent a breast augmentation revision procedure with an unspecified mentor gel breast prosthesis has silicone in her right lymph nodes post implantation.Mammogram results indicated that there was no rupture of the breast prosthesis.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.A catalog number (354-148g) was reported for the suspect medical device.However, mentor cannot confirm that this belongs to a mentor product.If clarification is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
On 29-feb-2024, mentor received additional information about the event: additional information was reported about the identity of the suspect medical device.The correct product code is 3541458g.The suspect medical device is a mentor memoryshape breast implant 480cc gel breast prosthesis, lot #257446, udi #(b)(4), pma #p060028.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.A healthcare professional diagnosed bilateral rupture of the breast prostheses.This medwatch report is for the patient¿s right breast prosthesis.Refer to manufacturer report number 1645337-2024-03471 for the report for the patient¿s left breast prosthesis.The reported implantation date is before the manufacture date of the suspect medical device.Mentor will report the implantation date as received.If clarification is received, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 03-sep-2024, mentor received additional information about the event.The patient was scheduled to undergo bilateral explantation on (b)(6) 2024.Reason for device explant and/or reoperation: bilateral breast prosthesis rupture, silicone in right lymph nodes.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 24-oct-2024, the mentor failure analysis lab received the device for evaluation.Additionally, an updated explantation date (on (b)(6) 2024) was reported.The patient¿s explanted breast prostheses were replaced with mentor memorygel boost breast implant 630cc gel breast prostheses.On 28-oct-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant.Additionally, silicone was found in the lymph nodes.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured and it was received in two (2) parts.Additionally, siltex cracking was observed on the edges of the rupture.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: 18778769
• Report Number: 1645337-2024-02338
• Device Sequence Number: 4319873
• Product Code: FTR
• UDI-Device Identifier: 00081317005506
• UDI-Public: 00081317005506
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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: 02/29/2008
• Device Catalogue Number: 3541458G
• Device Lot Number: 257446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 09/03/2024; 10/24/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/20/2024; 09/16/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2003
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White