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

Model Number SMXP130RH

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

During the visual evaluation, two tears were observed in the anterior patch.Tear a measuring approximately 0.5 cm and tear b measuring approximately 2.0 cm.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 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 right-sided device.

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-868
• MDR Report Key: 10600822
• MDR Text Key: 208991355
• Report Number: 1645337-2020-12185
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1