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

Model Number	3545535
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number (b)(4).Mentor¿s psr exemption #e2007003.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: mentor memorygel 535cc silicone breast implant, sn#:778105-024; cat#: 3545535.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains supplemental information for mentor psr reference number (b)(4).Mentor¿s psr exemption #e2007003.It was reported that a (b)(6) female patient underwent a primary breast augmentation with mentor memorygel 535cc silicone breast implants which the right side ruptured after implantation.As a result patient underwent bilateral removal and replacement as follow: right replaced with catalog number smpx-295, serial number (b)(4), and left replaced with catalog number smpx-295, serial number (b)(4) on (b)(6) 2019.
Additional Manufacturer Narrative
Device evaluation summary: during visual evaluation of the device, a tear measuring 17.8 cm was observed on the anterior view and extending to the posterior view.Additionally, an area of delamination with leak was noted on the posterior view.Microscopic examination was performed and the cause of the tear could not be identified.Rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing 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 (b)(6) 2020, mentor became aware that the concomitant product cat, and sn number mistakenly reported incorrect, the correction is as follow: cat# 3545535, and sn#:(b)(4).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: 9186014
• Report Number: 1645337-2019-21627
• Device Sequence Number: 11337289
• Product Code: FTR
• UDI-Device Identifier: 00081317007180
• UDI-Public: 00081317007180
• 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
• Report Date (Section B): 08/02/2019

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: 03/16/2020
• Device Model Number: 3545535
• Device Catalogue Number: 3545535
• Device Lot Number: 6913108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 01/24/2020; 05/05/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 01/27/2020; 05/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR