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

Model Number	TEXP130RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 475cc mentor artoura breast tissue expander and experienced postoperative deflation.As a result, the patient's impacted device was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6)2020, the product investigation was completed.Device investigation summary: during visual inspection of the device, it was observed with no apparent damage.Leak testing was performed and it revealed a tear in the anterior view, measuring approximately less than 0.1 cm.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.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.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.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: 9603704
• Report Number: 1645337-2020-00996
• Device Sequence Number: 3012943
• Product Code: LCJ
• UDI-Device Identifier: 00081317009474
• UDI-Public: 00081317009474
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 01/17/2023
• Device Model Number: TEXP130RH
• Device Catalogue Number: TEXP130RH
• Device Lot Number: 7673655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/06/2020
• 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