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

Catalog Number	TEXP130RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the device was returned to mentor without fluid inside.No foreign material was observed within the device or on the shell surface.Mentor product analysis lab discovered a rent at the patch junction of the anterior aspect.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.A manufacturing record evaluation (mre) of lot number 7396548 was reviewed, 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.There is no evidence that the issue is related to manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices as referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent primary breast reconstruction with a mentor artoura 650cc breast tissue expander that deflated postoperatively.On (b)(6) 2019, during surgery to remove the device, a hole was identified on the junction patch near the filling port.

• 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: 8562989
• Report Number: 1645337-2019-10759
• Device Sequence Number: 1666467
• Product Code: LCJ
• UDI-Device Identifier: 00081317009559
• UDI-Public: 00081317009559
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 12/03/2020
• Device Catalogue Number: TEXP130RUH
• Device Lot Number: 7396548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: 50 YR