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

Model Number	SMXP120RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent breast augmentation revision with a 375cc mentor artora breast tissue expander and experienced deflation on the right side postoperatively.As a result, underwent device removal and replacement with an unspecified mentor tissue expander on (b)(6) 2019.
Additional Manufacturer Narrative
On april 29, 2020, the product investigation was completed.Device investigation summary: during visual evaluation of the sample, no apparent damage was observed.Additionally blue liquid inside the device was noticed and multiple attempts have been made to obtain a clarification of it.However, no additional information has been provided.Leak testing was performed in accordance with mentor's procedures.There were no leak sites confirmed.Unfortunately, after a thorough analysis we were unable to confirm the reported event.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.As stated in the product insert data sheet, it is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection since this could compromise the product integrity.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 9818450
• Report Number: 1645337-2020-03992
• Device Sequence Number: 13894982
• Product Code: LCJ
• UDI-Device Identifier: 00081317024309
• UDI-Public: 00081317024309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• 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): 02/13/2020

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: 02/03/2023
• Device Model Number: SMXP120RH
• Device Catalogue Number: SMXP120RH
• Device Lot Number: 7682058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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