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

Model Number	SMXP130RH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the visual evaluation, a tear was noted in the anterior patch, measuring approximately 0.7 cm.Additionally, an area of missing material measuring approximately 1.2 cm x 1.4 cm was noted at the junction at the shell and patch.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.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Reason for device explant and/or reoperation: ni.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
On (b)(6) 2020, a 475cc artoura breast tissue expander that was returned to mentor for analysis was found to be deflated.The reason for explant was not provided, but with the information available, it was determined that the device was explanted as part of a staged reconstruction.A 375cc mentor memorygel device was implanted in its place (catalog # 3503751bc, s/n (b)(4)).There were no reports of any device issue or patient consequence, and multiple follow-up attempts were made without receiving a response.Mentor will report this event based on the analysis findings, and if any additional information is received in the future, a supplemental report will be submitted.This report is for the patient¿s left-sided device.

• 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: 10600824
• Report Number: 1645337-2020-12091
• Device Sequence Number: 14195354
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• 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
• Report Date (Section B): 09/16/2020

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: 03/22/2023
• Device Model Number: SMXP130RH
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 7703112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1