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

Model Number	SMXP140RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2020
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 of left breast tissue expander.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient underwent a primary breast reconstruction procedure with an artoura breast tissue expander 600cc device that deflated after implantation.The patient noticed that her left breast was flat.A leak in the left breast tissue expander was reported.As a result, the patient underwent explantation and replacement with an unspecified mentor tissue expander on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a deflation on the tissue expander.During visual evaluation of the device, a tear was observed at the union between shell and suture tab at the 6 o¿clock position.Microscopic examination was performed and the cause of the rupture could not be identified.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 08-jul-2024, mentor received additional information about the event.The explanted left breast tissue expander was replaced with a mentor artoura breast tissue expander 600cc device.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9709072
• Report Number: 1645337-2020-02388
• Device Sequence Number: 19668359
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2020

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: 10/13/2023
• Device Model Number: SMXP140RH
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 9376464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 07/08/2024
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/03/2020; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White