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

Model Number	3542450M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	01/10/2020
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 baker grade ii (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast reconstruction revision with mentor siltex round spectrum, 325cc saline breast implants which the right side deflated and left side has issue with capsular contracture baker grade ii after implantation.The issue was confirmed by the physician.As a result patient had the implants removed on (b)(6) 2020.This report is for the left side.
Additional Manufacturer Narrative
Updated device evaluation completed on july 9th, 2020: during visual evaluation no apparent damage or visual anomalies were observed on the returned device.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.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 3/3/2020, additional information indicated that the date of event was on (b)(6) 2020, and the replacement devices were mentor.This report is for the right side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has 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).
Additional Manufacturer Narrative
Device evaluation summary: the sample was visually inspected and no apparent damage was found.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.An investigation of the returned device was performed, and mentor could not uncover a device failure that we could connect to the reported medical symptoms.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.Additional information received on 3/27/2020, indicated that the date of event was on 1/10/2020.Patient underwent bilateral removal and replacement as follow: left replaced with cat#:3502425, lot#:9411927, and right replaced with cat#:3502425, sn#:(b)(6).This report is for the left side.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9751918
• Report Number: 1645337-2020-03023
• Device Sequence Number: 2421906
• Product Code: FWM
• UDI-Device Identifier: 00081317002093
• UDI-Public: 00081317002093
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/03/2020

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 Model Number: 3542450M
• Device Catalogue Number: 3542450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 03/03/2020; 03/25/2020; 07/09/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 02/26/2020; 03/04/2020; 03/27/2020; 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR