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

Catalog Number	3542610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: mentor siltex round moderate profile 125 cc saline catalog: 3542610 lot: 230331.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor siltex round moderate profile 125 cc breast prostheses.Bilateral deflation was diagnosed by ultrasonography.As a result, the patient underwent bilateral removal and replacement with mentor memorygel breast implant 150 cc gel and a mentor cpg 311 gel breast prostheses on (b)(6) 2018.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
Upon receipt to mentor, the device contained no fluid.Brown material was observed within the device.Yellow material was observed on the shell surface.Visual evaluation of the device revealed two rents within an area of siltex cracking on the anterior and posterior views; rent a measuring approximately 0.2 cm and rent b measuring approximately 0.5 cm.No other anomalies were found.Because mentor performs 100% inspection and testing of all devices prior to release, product evaluation concluded that the rents and siltex cracking occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since two rents were found on the device.However, at this point it is not possible to determine the root cause of such damage or the origin of the brown and yellow material observed.Because mentor performs 100% inspection and testing of all devices prior to release, product evaluation concluded that the rents 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 breast prostheses.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7739734
• Report Number: 1645337-2018-04666
• Device Sequence Number: 1398023
• Product Code: FWM
• UDI-Device Identifier: 00081317001713
• UDI-Public: 00081317001713
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: 08/31/2005
• Device Catalogue Number: 3542610
• Device Lot Number: 230331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR