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

Catalog Number	SMXP155RH
Medical Device Problem Codes	Material Rupture (1546); Connection Problem (2900)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.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, broken suture tab.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent breast reconstruction with a 850cc artoura breast tissue expander on (b)(6) 2019, experienced left breast tissue expander deflation.During revision on (b)(6) 2019, it was noted that there was a hole in the expander where the 6 o¿clock suture tab tore away from the expander.Per sales rep, it was not the surgeon who nicked the implant, but rather, the tab tore off the device, causing deflation.As a result, the patient underwent unilateral removal and replacement with a new 850cc artoura breast tissue expander.
Additional Manufacturer Narrative
On 10/21/2019, the product investigation was updated.Device investigation summary: during the evaluation of the device, it was noticed a little hole in the union between a suture tab and shell at the posterior aspect.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.No additional anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.As part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment, however, since no potential cause could be established during the analysis an investigation was opened to determine and address the root cause as appropriate, including but not limited to additional investigation related to design and manufacturing.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 7/10/2019, the mentor failure analysis lab has received the device for evaluation.On 7/19/2019, the product investigation was completed.Device investigation summary: during the evaluation of the device, it was noticed a little hole in the union between a suture tab and shell at the posterior aspect.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.No additional anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Deflation is a known complication associated with tissue expander.Possible causes of deflation of saline-filled tissue expander include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Deflation is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected 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: 8717434
• Report Number: 1645337-2019-14219
• Device Sequence Number: 2386493
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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: 03/12/2023
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7690026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 10/21/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/22/2019; 10/22/2019
• 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: 36 YR