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

Model Number	TEXP120RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2019
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent primary breast reconstruction surgery with 375cc artoura breast tissue expander experienced right sided deflation post procedure.As a result, patient had an explantation on (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2020.Device evaluation summary: according to the information provided, it was reported that the patient experienced a deflation on the artoura breast tissue expander.During visual evaluation of the sample it was noticed a leakage at the union between shell and patch.Microscopic examination was performed, and no evidence of instrument damage was observed.Possible causes of deflation 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.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.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: 9537274
• Report Number: 1645337-2020-00009
• Device Sequence Number: 11346490
• Product Code: LCJ
• UDI-Device Identifier: 00081317009467
• UDI-Public: 00081317009467
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 08/03/2019
• Device Model Number: TEXP120RH
• Device Catalogue Number: TEXP120RH
• Device Lot Number: 6960120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/30/2020
• 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: 60 YR