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

Catalog Number	SMXP155RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2019
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 (b)(6) year old caucasian female who underwent breast reconstruction revision with an 850cc artoura breast tissue expander experienced left sided deflation post procedure.As a result, unilateral prosthesis replacement with an unknown device was performed.The patient has fully recovered with no residual effects.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2019.Device evaluation summary: according to the information received, it was reported a patient experienced a deflation of their tissue expander.A manufacturing record evaluation (mre) was performed for the finished device number 7680126, and no non-conformance's related to the reported complaint were identified.During evaluation of the sample a tear in a suture tab measuring approximately 1 cm was found.Microscopic examination was performed to the tear and no evidence of instrument damage was observed.No other anomalies were discovered.Deflation is a known complication associated with mentor mammary tissue expander devices.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.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: 9293349
• Report Number: 1645337-2019-23374
• Device Sequence Number: 2310444
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• 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

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: 02/10/2023
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7680126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: 49 YR