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

Catalog Number	3542440M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2018
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: a saline mentor siltex round spectrum 275cc, catalog number 3502440m, serial number (b)(4), lot number 255266.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation primary with a saline mentor siltex round spectrum 275cc and experienced deflation on the left breast implant.As a result, the patient had undergone removal and replacement with gel mentor memorygel breast implant 450cc on (b)(6) 2018.
Additional Manufacturer Narrative
On 08/22/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device returned with brownish fluid.Brown material was observed within the device.Brown and white material was observed on the shell surface.Pe discovered a rent measuring approximately 0.3 cm within an area of siltex cracking at the posterior aspect.Also was noticed lines of shell wear at the anterior aspect, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.At this point, is not possible to determine the etiology of the brown and white material found on the device.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex 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 breast implants.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.There is no evidence that the issue is related with manufacturing.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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).
Additional Manufacturer Narrative
On 08/07/18, it was reported to mentor that the patient¿s race was caucasian.The problem was diagnosed via a physical exam.The patient was not hospitalized.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: 7783192
• Report Number: 1645337-2018-04914
• Device Sequence Number: 19180386
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2018

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: 01/31/2007
• Device Catalogue Number: 3542440M
• Device Lot Number: 255266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 07/25/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/06/2018
• 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: 46 YR