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

Model Number	3545455
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/07/2019
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 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: rupture.Concomitant products: 455cc mentor memorygel breast implant, catalog # 3545455, serial # (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast augmentation primary with a 455cc mentor memorygel breast implant and experienced postoperative left-sided rupture, confirmed by a physician.As a result, the patient underwent removal and replacement with 400cc mentor memorygel breast implant, catalog # 3504004bc, left serial # (b)(4) and right serial # (b)(4) on (b)(6) 2019.
Additional Manufacturer Narrative
Device evaluation summary: according with the information reported the patient experienced a rupture in the breast implant.During visual analysis of the sample was found rupture.Microscopic examination of the edges of the rupture revealed parallel striations.No other anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.The striations are consistent with markings made by a sharp instrument perforating silicone material.As stated in the product insert data sheet, do not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures as this can result in rupture.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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02-jan-2020, mentor became aware that the patient also experienced postoperative bilateral pseudoptosis.This medwatch report is for the left-sided implant.Refer to manufacturer report number 1645337-2020-01262 for report on the contralateral device.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: 9292858
• Report Number: 1645337-2019-23350
• Device Sequence Number: 2310508
• Product Code: FTR
• UDI-Device Identifier: 00081317007166
• UDI-Public: 00081317007166
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2019

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: 10/04/2017
• Device Model Number: 3545455
• Device Catalogue Number: 3545455
• Device Lot Number: 6639373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 01/02/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/02/2019; 01/26/2020
• 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: 34 YR