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

Catalog Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2019
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 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.Concomitant products: artoura breast tissue expander 500cc, catalog number smxp135rh, serial number (b)(4), lot number 7625055.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast reconstruction primary with artoura breast tissue expander 500cc and experienced deflation on the right tissue expander.As a result, the patient had undergone removal on (b)(6) 2019.
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained clear fluid.No foreign material was observed within the device or on the shell surface.During the initial evaluation the device appeared intact.Leak testing was performed according with mentor procedures and it revealed a rent at the injection dome juncture.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were observed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.A manufacturing record evaluation (mre) was performed for the finished device number: 7496978 and no non-conformances related to the reported complaint condition were identified.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).

• 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: 8374766
• Report Number: 1645337-2019-08904
• Device Sequence Number: 11355321
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 08/10/2021
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7496978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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: 44 YR