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

Model Number	SMXP135RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2020
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: right tissue expander deflation.Manufacturer¿s reference number:(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a primary breast reconstruction procedure with an artoura breast tissue expander 700cc device that deflated after implantation.Deflation of the patient¿s right breast tissue expander was reported.As a result, the patient underwent explantation and replacement with an artoura breast tissue expander 700cc device on (b)(6) 2020.
Additional Manufacturer Narrative
On 22-apr-2020, the mentor failure analysis lab received the device for evaluation.On 03-may-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, a deflation occurred in a tissue expander.Upon visual evaluation of the device, a tear was observed at the union between shell and suture tab at 6 o¿clock position.Microscopic examination was performed, and the cause of the rupture could not be identified.As part of our quality process, the manufacturing records of lot 7678995 were reviewed and the manufacturing standards 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 and functionally tested 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).

• 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: 9889235
• Report Number: 1645337-2020-04924
• Device Sequence Number: 19687806
• Product Code: LCJ
• UDI-Device Identifier: 00081317024408
• UDI-Public: 00081317024408
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 01/30/2023
• Device Model Number: SMXP135RUH
• Device Catalogue Number: SMXP135RUH
• Device Lot Number: 7678995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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: 55 YR