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

Catalog Number	TEXP120RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/21/2018
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.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 medical products: artoura breast tissue expander 375cc , catalog number texp120rh , serial number (b)(4), lot number 7413822 manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast reconstruction with a artoura breast tissue expander 375cc and experienced deflation on the right tissue expander.The deflation was noticed by the doctor as the doctor observed the slow leak in the tissue expander.As a result, the patient had undergone removal and replacement with mentor gel memory shape gel device on (b)(6) 2018.There were no complications after the surgery.
Additional Manufacturer Narrative
On 06/30/18, it was reported to mentor that the mentor failure analysis lab has received the device for evaluation.Device was processed on 07/02/2018.On 07/18/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device was received with no fluid.Brown and yellow material was observed on the shell surface.The device appeared intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation team was precluded from further evaluating the device.No other anomalies were observed.Complaint was not confirmed.Mentor performs 100% inspection and testing of all devices prior to release.A root cause of the failure could not be determined.At this time is not possible to determine the origin of the brown and yellow material observed.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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: 7586848
• Report Number: 1645337-2018-03569
• Device Sequence Number: 16187154
• Product Code: LCJ
• UDI-Device Identifier: 00081317009467
• UDI-Public: 00081317009467
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 08/09/2020
• Device Catalogue Number: TEXP120RH
• Device Lot Number: 7359781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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: 51 YR