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

Catalog Number	3545400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.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: no information regarding explantation or an expected explantation date has been received.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient underwent a primary breast augmentation with mentor memorygel breast implants 400cc and experienced capsular contracture on the right side (baker grade iii) and a possible rupture on the left side implant.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side implant.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2019.An explant is planned for (b)(6) 2019.2.Is other serious-uncheck.2.Is required intervention-check.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 8/29/2019.Device evaluation summary: according to the information reported the patient experienced a rupture.During evaluation of the device it was observed to be ruptured and was received in three parts.Microscopic examination of the edges of the tear gave no indications as to cause of the failure.No other anomalies were observed.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to, the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal daily routines including customary and purposeful trauma to the breast.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2019.The explant was performed on (b)(6) 2019, rather than (b)(6) 2019, as reported previously.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANTS
• 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: 8698069
• Report Number: 1645337-2019-13840
• Device Sequence Number: 2662995
• Product Code: FTR
• UDI-Device Identifier: 00081317007142
• UDI-Public: 00081317007142
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/17/2019

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: 11/12/2020
• Device Catalogue Number: 3545400
• Device Lot Number: 6997910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 08/06/2019; 09/10/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/11/2019; 09/03/2019; 10/04/2019
• 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: Other; Required Intervention
• Patient Age: 25 YR