MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501490
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/06/2023
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.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.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 breast augmentation revision with a mentor smooth round spectrum 575cc saline prosthesis experienced right sided deflation post procedure.The deflation was diagnosed through a physical examination.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.The patient had an event reported with her previous set of implants under 1645337-2023-04991 and 1645337-2023-04990.
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on april 8, 2024.The investigation of the returned device was completed by the failure analysis lab on april 15, 2024.Device evaluation summary: the product was returned to mentor for evaluation, the tubing, the connector, and the injection port were not returned.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and three (3) tears were noted, tears a and b on the anterior view measuring approximately 0.1 cm and less than 0.1 cm respectively, and tear c on the posterior view at valve.Microscopic examination was performed on the edges of the tears, and parallel striations were found in the whole area of all tears.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, a 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 not to 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.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).
Additional Manufacturer Narrative
Additional information was received on march 1, 2024.Explant and replacement with non mentor was performed on (b)(6) 2024.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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 18440296
• Report Number: 1645337-2024-00123
• Device Sequence Number: 17900840
• Product Code: FWM
• UDI-Device Identifier: 00081317002048
• UDI-Public: 00081317002048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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

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: 05/01/2026
• Device Catalogue Number: 3501490
• Device Lot Number: 9730814
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 03/01/2024; 04/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/21/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White