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

Model Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2019
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation of tissue expander.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent breast surgery with an artoura breast tissue expander 500cc device that deflated after implantation.As a result, the patient underwent explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On 04-mar-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information provided, the patient experienced a deflation on the tissue expander.During visual evaluation of the sample, a tear was observed at the union between shell and suture tab at the 6 o¿clock position.In addition, the device was received with brown liquid inside.Microscopic examination was performed and the cause of the rupture could not be identified.Multiple attempts have been made to obtain clarification regarding the brown liquid inside the device; however, it has not been made available.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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.Although the manufacturing criteria was met during manufacturing, there is an open investigation 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 31-jan-2020, the mentor failure analysis lab 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.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: 9639245
• Report Number: 1645337-2020-01432
• Device Sequence Number: 2883808
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 09/25/2023
• Device Model Number: SMXP135RH
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 9363783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 03/04/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/24/2020; 03/05/2020
• 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: 47 YR