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

Model Number	SMXP155RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2019
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.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with mentor artoura breast tissue expander 850cc saline device which patient experienced bilateral deflation after implantation.Left expander had a leak from where the valve expands itself.The issue was confirmed by the physician.As a result patient had the left device removed and replaced with another device on (b)(6) 2019.On (b)(6) 2020, mentor received additional information indicating that post-op follow up on (b)(6) 2019 demonstrated deflating right breast expander.Immediate new fluid collection was noted of the right breast.Superficial aspiration removed 60 cc.This is confirming a leak of the expander.On (b)(6) 2019 bilateral breast replacement of tissue expander with permanent silicone implants with cat#: 3508004bc performed.This report is for the right side.
Additional Manufacturer Narrative
Device evaluation completed on october 9 2020: during visual evaluation of the device no apparent damage was observed.Leak testing was performed in accordance with mentor's procedures.There were no leak sites confirmed.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing breast implants are not considered lifetime devices and deflation/rupture is a known complication associated with these devices and is 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: 10373729
• Report Number: 1645337-2020-09725
• Device Sequence Number: 2801061
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 06/02/2023
• Device Model Number: SMXP155RH
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7727827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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: 42 YR