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

Model Number	3503001BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 62-year-old caucasian female patient underwent a breast augmentation revision surgery with a 300cc mentor memorygel breast implant.Post-operatively, the patient experienced a rupture of her right prosthesis, which was confirmed via magnetic resonance imaging.As a result, the patient is scheduled for removal on (b)(6) 2023.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
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.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.Date of explant: (b)(6) 2023.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 16, 2023, mentor received the device for evaluation.On august 17, 2023, mentor completed a visual inspection of the returned device.Device evaluation summary: visual analysis of the returned sample revealed that the breast implant was found to have an area of delamination at the union between the patch and shell, causing gel leakage.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Although potential causes of patch delamination are unknown, stresses and forces on the implant in-vivo or exposure to betadine at insertion could result in delamination and ruptures.Per the current product insert data sheet (pids), rupture is a known complication associated with these devices and can occur at any time during or after implantation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 27, 2023, mentor received additional information.Mentor became aware that the patient's rupture was first observed via magnetic resonance imaging on (b)(6), 2022.As such, the date of event has been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 19, 2023, mentor received the lot number of the device.Lot number: 265814.Expiration date: august 31, 2008.Manufacture date: august 01, 2003.On july 24, 2023, mentor evaluated a photo of the explanted device.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.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 august 07, 2023, mentor became aware that information was inadvertently submitted in the previous supplemental report.The impacted device was identified as a 500cc mentor memorygel breast implant.The serial number originally reported was found to conflict with this information and is no longer applicable to this file.Several attempts were made to clarify the identity of the impacted device, but no additional information was received.Manufacturer¿s reference number: (b)(4), in the previous report, d4.Catalog should have been populated with 3545001.D4.Unique identifier (udi) should have been populated with (b)(4).
Additional Manufacturer Narrative
On july 17, 2023, mentor completed a photo evaluation of the explanted device.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.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: 17172395
• Report Number: 1645337-2023-07362
• Device Sequence Number: 7032379
• Product Code: FTR
• UDI-Device Identifier: 00081317000921
• UDI-Public: 00081317000921
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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,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: 08/31/2008
• Device Model Number: 3503001BC
• Device Catalogue Number: 3545001
• Device Lot Number: 265814
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 07/17/2023; 07/24/2023; 08/07/2023; 08/16/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/10/2023; 07/18/2023; 07/25/2023; 08/08/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2003
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White