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

Catalog Number	SMXP140RH
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/08/2019
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: defective manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an unknown breast surgery with mentor artoura breast tissue expander 600cc breast implants which there was issue with right side after implantation.The issue was found by the physician.As a result patient had the device removed on (b)(6) 2019.
Additional Manufacturer Narrative
During the evaluation of the sample, it was observed to be intact.Leak testing revealed a rupture located on second suture tab.Microscopic examination was performed and evidence of damage was observed.No additional anomalies were discovered.The failure found may be the incident reported however, is unclear if that was the defect observed by the customer.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with 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: 8583164
• Report Number: 1645337-2019-11148
• Device Sequence Number: 2372389
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/09/2019

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: 11/09/2022
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 7631666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/30/2019
• 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: 61 YR