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

Catalog Number	TEXP120RUH
Medical Device Problem Codes	Connection Problem (2900); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/19/2018
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent breast reconstruction revision with a 535cc mentor artoura breast tissue expander.Left tissue expander's fill port was found to be defective upon explantation on (b)(6) 2018 and was replaced with a 475cc mentor memorygel breast implant.
Additional Manufacturer Narrative
Device evaluation and investigation findings: upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device.Brown material was observed on the shell surface.Mentor product analysis lab discovered a rent measuring approximately 16.5 cm on the anterior aspect.Microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were discovered.Potential cause: complaint for defect in the fill port was not confirmed.A manufacturing record evaluation (mre) of lot number 7348939 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 with manufacturing.Complaint for defect in the fill port was not confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.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: 8200244
• Report Number: 1645337-2018-07605
• Device Sequence Number: 16503754
• Product Code: LCJ
• UDI-Device Identifier: 00081317009542
• UDI-Public: 00081317009542
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: 07/05/2020
• Device Catalogue Number: TEXP120RUH
• Device Lot Number: 7348939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR