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

Catalog Number	3544501
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 450cc mentor memorygel breast implant prosthesis.Post-operatively, the patient desired further breast enlargement.As a result, she underwent bilateral removal and replacement with mentor memorygel boost breast implants.However, during the surgery, a ruptured right breast implant and a left breast implant with gel bleed were observed.There were no reported procedural delays or patient consequences due to the discovery.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2024-04499 for the contralateral event.
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.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.  reason for device explant and/or reoperation: breast augmentation revision0 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 15, 2024, the mentor analysis lab received the suspect medical device for evaluation.On april 17, 2024, mentor completed an evaluation on the returned device.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the breast implant had parallel lines of shell wear on the anterior aspect.Leak testing was performed, in accordance with mentor procedures, and no leak sites or gel exposure were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable leakage or gel exposure.Although no rupture 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.Manufacturer¿s reference number: (b)(4).In the initial, b5 event description should have indicated that the removal and replacement surgery occurred on (b)(6) 2024.

• 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: 19165364
• Report Number: 1645337-2024-04497
• Device Sequence Number: 7455994
• Product Code: FTR
• UDI-Device Identifier: 00081317000914
• UDI-Public: 00081317000914
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 04/23/2024

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: 11/05/2020
• Device Catalogue Number: 3544501
• Device Lot Number: 6995032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2015
• 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: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White