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

Catalog Number	3545535
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Breast Mass (2439); No Code Available (3191)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: material rupture, breast mass.Concomitant medical products: mentor memorygel breast implant 535cc, catalog# 3545535, serial# (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation with mentor memorygel breast implant 535cc and experienced a breast mass and a silent rupture on the right side post-operatively, which were confirmed by a physician.As a result, the patient underwent explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On 11/06/2019, the mentor failure analysis lab received the device for evaluation.On 11/15/2019, mentor completed evaluation of the device.Device evaluation summary: during evaluation of the sample, it was observed a tear in the union between shell and patch.Also parallel lines of shell wear in the same view.No other anomalies were discovered.The second product received is related to a concomitant device, there are neither deficiencies alleged nor patient injuries.Therefore, no further investigation is required.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).

• 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: 9211140
• Report Number: 1645337-2019-22105
• Device Sequence Number: 18944814
• Product Code: FTR
• UDI-Device Identifier: 00081317007180
• UDI-Public: 00081317007180
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/19/2019

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: 12/21/2020
• Device Catalogue Number: 3545535
• Device Lot Number: 7009322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: Required Intervention
• Patient Age: 31 YR