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

Catalog Number	3542620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/21/2018
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 325cc saline breast implant, catalog # 3542650, lot # 211867.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a primary breast augmentation with a saline mentor siltex round moderate profile 175cc and experienced deflation on the left breast implant.The deflation was confirmed via mammogram.As a result, the patient underwent removal of the implant on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation summary: it was reported that a 62 year old female patient underwent a primary breast augmentation with a saline mentor siltex round moderate profile 175cc and experienced deflation on the left breast implant.The deflation was confirmed via mammogram.As a result, the patient underwent removal of the implant on (b)(6) 2018.Two devices were returned to mentor without fluid inside.Brown material was observed within the device.Yellow, white, blue and brown material was observed on the shell surface.The mentor product analysis lab discovered on device a a rent measuring approximately 0.5 cm on the anterior aspect.Microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were discovered.On the other hand, device b presented several lines of shell wear on the anterior aspect, suggesting in-vivo folding or creasing of the device and two rents measuring 0.5 cm and 0.4 cm located on the posterior aspect.Both rents gave no evidence of instrument damaged under microscopic examination.No other anomalies were observed.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage or the etiology of the yellow, white, blue and brown material found on the device.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: 8197311
• Report Number: 1645337-2018-07569
• Device Sequence Number: 267849
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 05/31/2004
• Device Catalogue Number: 3542620
• Device Lot Number: 211429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR