MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	SMXP140RUH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Cancer (1759); No Consequences Or Impact To Patient (2199); No Code Available (3191)
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: breast cancer.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent an unknown breast reconstruction surgery with artoura breast tissue expander 850cc saline breast implants which the patient experienced breast cancer.As a result, patient underwent bilateral mastectomy, and bilateral exchange of tissue expander to saline implant as follow: left replaced with cat#:3502550, sn#:(b)(4), and right replaced with cat#: 3502550, sn#: (b)(4) on (b)(6) 2020.This report is for the left side.
Additional Manufacturer Narrative
This case was clinically reassessed on (b)(6) 2020.With the information available at this time, there appears to be no alleged complaint relating to the identity, quality, durability, reliability, usability, safety, effectiveness, or performance of this device.This appears to be a part of a staged reconstruction for a breast cancer patient post-mastectomy.Therefore, this event does not meet the criteria for a complaint at this time.Multiple attempts have been made to gain additional information and clarity, but none has been provided as of yet.However, should additional information be received in the future, this event will be reassessed.Manufacturer's reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10186849
• Report Number: 1645337-2020-07679
• Device Sequence Number: 14261335
• Product Code: LCJ
• UDI-Device Identifier: 00081317024415
• UDI-Public: 00081317024415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 07/28/2023
• Device Model Number: SMXP140RUH
• Device Catalogue Number: SMXP140RUH
• Device Lot Number: 7751324
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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