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

Model Number	SMXP140RH
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
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: to place permanent implant.(b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast reconstruction with a 600cc mentor artoura breast tissue expander secondary to intraductal carcinoma of the left breast had the device implanted for longer than six months.Per the instructions for use, these devices are not to remain implanted for longer than six months, meaning the device was used off-label.The expander was placed on (b)(6) 2019, and on (b)(6) 2020, was explanted and replaced with a permanent implant.With the information available at the time of this report, there is nothing to suggest that there were any device issues or patient consequences.This event is being conservatively reported to capture the off-label use of the device.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on december 20, 2020.The analysis has begun but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on november 12, 2020.Device evaluation summary: during the visual evaluation no apparent damage or visual anomalies were observed on the returned device.However, blue coloration on the shell was noted.Per mentor¿s instructions for use (ifu), tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off-label manner.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10672976
• Report Number: 1645337-2020-12980
• Device Sequence Number: 2743652
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• Combination Product (Y/N): N
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: SMXP140RH
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 9376092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 11/12/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/10/2020; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1