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

Model Number SMXP120RUH

Device Problems Material Rupture (1546); No Apparent Adverse Event (3189)

Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: according to the information received, the patient underwent explantation as a result of breast mastectomy/reconstruction.During the visual evaluation, a tear in the anterior aspect was noted measuring approximately 1.9 cm.Reason for device explant and/or reoperation: not applicable.(b)(4).

Event Description

On (b)(6) 2020, a 535cc 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.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.

Manufacturer Narrative

On january 22, 2021 after further review of file based on the information available no patient consequence and no adverse event was reported.Therefore, no further reports will be sent to the fda.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10624122
• MDR Text Key: 209768890
• Report Number: 1645337-2020-12509
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317024385
• UDI-Public: 00081317024385
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: SMXP120RUH
• Device Catalogue Number: SMXP120RUH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1