MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3546001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/27/2018
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: left- mentor memorygel sx mpp gel 400 cc, gel breast implant, catalog number 3544001, lot number 265575.(b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with mentor memorygel sx mpp gel 400 cc, gel breast implant on the left and on the right mentor memorygel siltex round moderate profile 600 cc which the left side ruptured, and issue with capsular contracture bilaterally after implantation.The issue was diagnosed during the surgery.As a result patient underwent removal and replacement with allergan devices as follow: right catalog number ssm-640, serial (b)(4), and left replaced with catalog number ssm640, serial (b)(4) on (b)(6) 2018.This report is for the right.
Additional Manufacturer Narrative
On 8/6/2018,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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the gel contained in the device appears clear.No foreign material was observed within the device.White material was observed on the shell surface.Upon initial inspection the device appears intact.No other anomalies were discovered.Capsular contracture is the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Mentor product analysis lab concluded the reported complaint of 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.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7677733
• Report Number: 1645337-2018-04190
• Device Sequence Number: 1369943
• Product Code: FTR
• UDI-Device Identifier: 00081317000945
• UDI-Public: 00081317000945
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 3546001
• Device Lot Number: 265576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2018
• Initial Date Received by Manufacturer: 07/08/2018
• Supplement Date Received by Manufacturer: 07/08/2018; 11/20/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/07/2018; 11/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR