MAUDE Adverse Event Report: MENTOR TEXAS SAL SILTEX RND DIAP PKG 350CC; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
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.Reason for device explant and/or reoperation: capsular contracture.Section d6b, date of explant: (b)(6) 2024.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 implanted with two unspecified mentor smooth saline breast prostheses experienced capsular contracture baker grade 3 on the left side and a rupture on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.This report is for the left side device.
Additional Manufacturer Narrative
On march 7, 2024, mentor completed evaluation of the device.Device evaluation summary: 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 sal siltex rnd diap pkg 350cc breast implant was found to be ruptured and received in two parts.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the rupture, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.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, capsules, and effusion to pathology for examination.  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 is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 29, 2024, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: SAL SILTEX RND DIAP PKG 350CC
• 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: 18438281
• Report Number: 1645337-2024-00087
• Device Sequence Number: 7024347
• Product Code: FWM
• UDI-Device Identifier: 00081317001805
• UDI-Public: 00081317001805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2019
• Device Catalogue Number: 3542655
• Device Lot Number: 6915458
• 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: 02/29/2024; 03/07/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/04/2024; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2015
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White