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

Model Number	SMXP120RUH
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10624122
• Report Number: 1645337-2020-12509
• Device Sequence Number: 2793167
• Product Code: LCJ
• UDI-Device Identifier: 00081317024385
• UDI-Public: 00081317024385
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 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
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 10/03/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1