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

Model Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: material rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient who underwent primary breast reconstruction with a 500cc artoura breast tissue expander on the right breast, suffered breast implant deflation, post-operatively.As a result, the patient underwent removal and replacement with a non-mentor silicone implant on (b)(6) 2020.
Additional Manufacturer Narrative
On april 3, 2020, the product investigation was completed.Device investigation summary: the device was analyzed and no apparent damage could be identified.Leak testing was performed in accordance with mentor procedures and no leak sites were found.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, 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: 9780548
• Report Number: 1645337-2020-03490
• Device Sequence Number: 713904
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: SMXP135RH
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7739425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR