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

Catalog Number	SMXP155RH
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2019
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: migration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female who had 850cc artoura breast tissue expanders placed experienced right sided deflation and left sided rotation post procedure.The right sided suture tab tore away from the shell, and left sided sutures tore.As a result, bilateral replacement with 850cc artoura breast tissue expanders was performed.This report relates to the left prosthesis.See 1645337-2019-15166 for contralateral prosthesis report.
Additional Manufacturer Narrative
The investigation of the photograph provided was completed by the failure analysis lab on (b)(6) 2019.Device evaluation summary: according to the information received, it was reported that left tissue expander had all sutures torn, and the expander completely rotated causing device migration.Upon visual inspection of the picture a tear in one of the suture tabs was noted.No other anomalies were noted.The photos do not provide enough evidence to determine root cause.It is possible the rotation was caused due to the issue with the suture tab.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, no potential cause could be established since the device was not returned for analysis.An investigation was opened to determine and address the root cause of the suture tab breakage, including but not limited to, additional investigation related to design and manufacturing.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 8/13/2019 mentor became aware that the device code for material separation was erroneously omitted from the initial report.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: 8778711
• Report Number: 1645337-2019-15167
• Device Sequence Number: 19467921
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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: 02/26/2023
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7686368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/13/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/13/2019; 08/13/2019
• 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: 34 YR