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

Model Number	SMXP130RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/18/2019
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.Concomitant products: artoura breast tissue expander 475cc device, catalog # smxp405, serial # (b)(4).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 475cc device that deflated after implantation.Deflation of the patient¿s left breast tissue expander was reported.As a result, the patient underwent explantation and replacement with a mentor memorygel breast implant 405cc gel breast prosthesis on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6)2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, it was reported a deflation on the tissue expander.The device was visually inspected and it was found with no apparent damage.Leak testing revealed leakage at the union between shell and suture tab (at 3 o'clock position).Microscopic examination was performed and the cause of the rupture could not be identified.Possible causes of deflation of tissue expander implants 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.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 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 address with the defects of the suture tabs on the tissue expander as seen by the customer.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: 9541434
• Report Number: 1645337-2020-00141
• Device Sequence Number: 2340883
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 10/15/2021
• Device Model Number: SMXP130RH
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 7516192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/28/2020
• 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