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

Catalog Number	3542912
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor asr reference number (b)(4).Device evaluation summary: upon receipt to mentor, the device contained no fluid and could not be weighed.Brown material was observed within the device.Yellow and brown material was observed on the shell surface.Visual evaluation of the device revealed a rent measuring approximately 0.4 cm near an area of siltex cracking on the posterior aspect.No other anomalies were observed.Because mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent and siltex cracking occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rent was found on the device.However, at this point it is not possible to determine the root cause either of such damage or of the material observed within the device and on the shell surface.Because mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent and siltex cracking occurred sometime subsequent to the removal of the device from its protective packaging.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex saline-filled devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds (i.E., severe ¿v¿ or tight folds) in the rtv shell of siltex saline mammaries.No corrective action is required since there is no evidence that the failures modes are related with manufacturing or product design.Causes of deflation of saline-filled 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, manual massage, and intimate physical contact; stress or trauma to the breast, mechanical damage prior to or during surgery, valve malfunctions or tissue ingrowth into the valve, leakage from the fill tube, valve or injection dome (spectrum devices), underfilling or overfilling the implant (see product label), damage from surgical instruments, damage during fill tube removal, damage during the filling stage, closed capsulotomy, shell abrasion, capsular contracture, and origins which are simply unknown.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.Reason for device explant and/or reoperation: right deflation.Initial reporter phone number: (b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains supplemental information for mentor asr reference number (b)(4).It was reported that a (b)(6) year-old female patient underwent unspecified breast surgery with a 275/300cc mentor siltex contour profile moderate and was presented with right side deflation postoperatively.As a result, the device was explanted on (b)(6) 2017.On (b)(6) 2019, mentor became aware that asr submission reference numbers (b)(4) were duplicated.Any additional event information received will be reported under this manufacturer's report number.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9142344
• Report Number: 1645337-2019-20619
• Device Sequence Number: 1782903
• Product Code: FWM
• UDI-Device Identifier: 00081317001867
• UDI-Public: 00081317001867
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: 05/31/2015
• Device Catalogue Number: 3542912
• Device Lot Number: 6474735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/01/2019
• 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: 45 YR