MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE HIGH; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542711
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision procedure with mentor siltex round moderate profile 325cc saline breast prostheses that both deflated post implantation.Additionally, the patient developed baker grade ii capsular contracture in her left breast post implantation.As a result, the patient underwent bilateral explantation and replacement with mentor memorygel breast implant 450cc gel breast prostheses on (b)(6) 2024.This medwatch report is for the patient¿s left breast prosthesis.
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 review could be performed.Reason for device explant and/or reoperation: bilateral breast prosthesis deflation, left breast capsular contracture.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).
Additional Manufacturer Narrative
On 22-jul-2024, mentor received additional information about the event.It was previously reported that the suspect medical device is a mentor siltex round moderate profile 325cc gel breast prosthesis, catalog #3542650, udi #(b)(4).Mentor became aware that the suspect medical device is actually a mentor siltex contour profile high 275cc gel breast prosthesis, catalog #3542711, udi #(b)(4).The mentor failure analysis lab received the device for evaluation on the same date.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.D4: udi: as only the catalog number for the device involved in the event was provided, the full udi is currently not available.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 09-aug-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according with the information received, the patient experienced deflation in the breast implant and developed capsular contracture.The product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing 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 no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect 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.Mentor concluded that the capsular contracture in the patient¿s breast was the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, 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 SILTEX CONTOUR PROFILE HIGH
• 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: 19625784
• Report Number: 1645337-2024-07744
• Device Sequence Number: 17770304
• Product Code: FWM
• UDI-Device Identifier: 00081317001904
• UDI-Public: 00081317001904
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 3542711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 08/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 49 YR
• Patient Sex: Female