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

Model Number	SMXP110RUH
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020, 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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: ¿failed expander¿.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with an artoura breast tissue expander 455cc.The device was reported as a ¿failed expander¿ and no more additional details are available at this time.The side is unknown.Once more details are available, a supplemental report will be submitted.As a result, the patient had undergone removal on (b)(6) 2020.
Additional Manufacturer Narrative
On 3/26/2020, the device was visually inspected and a tear was noted at the union between shell and patch on the anterior view.Microscopic examination was performed and the cause of the rupture could not be identified.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Deflation is a known complication associated with mentor mammary tissue expander.Possible causes of deflation of tissue expander include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.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: 9745286
• Report Number: 1645337-2020-02884
• Device Sequence Number: 19286440
• Product Code: LCJ
• UDI-Device Identifier: 00081317024378
• UDI-Public: 00081317024378
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: SMXP110RUH
• Device Catalogue Number: SMXP110RUH
• Device Lot Number: 7674438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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