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

Catalog Number	TEXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2019
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 (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.Reason for device explant and/or reoperation: unknown side deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient with unknown name, race, sex, and gender underwent unspecified breast surgery with a 500cc artoura breast tissue expander and was presented with unknown side deflation.As a result, the expander was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
On 9/16/2019, 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.The returned device had marking "l" on it.Hence, the deflation side is left.Patient's identifier has been updated to (b)(6) as per paperwork received with device for analysis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, device evaluation was completed.Device evaluation summary: during evaluation of the sample it was observed to be intact.Leak testing revealed three tears at the union between shell and patch.No other anomalies were observed.Microscopic examination of the edges of the tear gave no indications of instrument damage.No other anomalies observed.Possible causes of deflation of tissue expander 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.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.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.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: 8995724
• Report Number: 1645337-2019-19050
• Device Sequence Number: 16927155
• Product Code: LCJ
• UDI-Device Identifier: 00081317009481
• UDI-Public: 00081317009481
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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: 03/15/2022
• Device Catalogue Number: TEXP135RH
• Device Lot Number: 7558810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 10/28/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 09/18/2019; 10/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention