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

Catalog Number	TEXP120RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/16/2018
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: 535cc artoura breast tissue expanders, catalog #texp120ruh, serial #(b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old caucasian female underwent breast reconstruction with 535cc artoura breast tissue expanders.On (b)(6) 2018, the tissue expanders were being removed right sided expander was noted to be completely deflation, and the left sided expander was thought to have deflated partially.The tissue expanders were there replaced with another set of 535cc artoura breast tissue expanders.The patient fully recovered without any additional issues.(see 1645337-2018-02765 for report on contralateral prosthesis).
Additional Manufacturer Narrative
The failure analysis lab completed the investigation of the returned device on 5/28/2018.Device evaluation summary: it was reported that a (b)(6) year-old caucasian female underwent breast reconstruction with 535cc artoura breast tissue expanders.The device contained fluid with clear appearance upon receipt by mentor.No foreign material was observed within the device or on the shell surface.During visual examination, the product evaluation team observed that the device appeared intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation team was precluded from further evaluating the device.No anomalies were found.Mentor performs 100% inspection and testing of all devices prior to release.The complaint of deflation was not confirmed since no anomalies were found on the reported device.No corrective action is required since there is no evidence that the failures modes are related with manufacturing or product design.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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: 7501121
• Report Number: 1645337-2018-02764
• Device Sequence Number: 16573083
• Product Code: LCJ
• UDI-Device Identifier: 00081317009542
• UDI-Public: 00081317009542
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 06/08/2019
• Device Catalogue Number: TEXP120RUH
• Device Lot Number: 6939679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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: 62 YR