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

Catalog Number	TEXP140RH
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2018
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 manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent primary breast reconstruction with a mentor artoura breast tissue expander 600cc on (b)(6) 2017 experienced right side expander deflation that was observed on (b)(6) 2018.The patient underwent explantation without replacement on (b)(6) 2018.Per mentor ifu, tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off label manner.
Additional Manufacturer Narrative
On 3/25/19, it was reported to mentor that a manufacturing record evaluation was performed for the finished device 6992234 number, and non-conformances were identified.An internal nonconforming report has been initiated to address the issue.On 12/10/2015, the manufacturing supervisor identified a discrepancy where the sheeting lot 7007725 part number 400574-003) was found with an expiration date of 01/07/2016.However, per the specification (drwg400574) the shelf life should be 4 weeks from the calendar date which is 12/30/2015.A second internal corrective action is being opened for the issue.Lots were erroneously added to a pd plan that was to be dispositioned as use as is.The lots are removed from the pd plan in the internal corrective action and system limitations will not allow the lots to be added to the same corrective action twice so a second corrective action is opened to disposition the product under a new pd plan.Per mentor ifu, tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off label manner.Since the product has not been returned, it has been concluded that deflation is a known complication associated with these devices as stated in the ifu.Therefore, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 6992234 number, and non-conformances were identified.Deflation is a known complication associated with mentor mammary prostheses.Causes of deflation of saline-filled implants include, but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, manual massage, and intimate physical contact; stress or trauma to the breast, mechanical damage prior to or during surgery, valve malfunctions or tissue ingrowth into the valve, leakage from the fill tube, valve or injection dome (spectrum devices), underfilling or overfilling the implant (see product label), damage from surgical instruments, damage during fill tube removal, damage during the filling stage, closed capsulotomy, shell abrasion, capsular contracture, and origins which are simply unknown.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: 8363100
• Report Number: 1645337-2019-08791
• Device Sequence Number: 1832858
• Product Code: LCJ
• UDI-Device Identifier: 00081317009498
• UDI-Public: 00081317009498
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 11/05/2019
• Device Catalogue Number: TEXP140RH
• Device Lot Number: 6992234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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: 48 YR