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

Catalog Number	TEXP140RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female had an 850cc artoura breast tissue expander implanted and that the tissue expander failed.This is indicative of deflation.The device was explanted on (b)(6) 2018.No additional information is available at this time.If additional information is made available in the future a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was received on 12/20/2018.The patient was caucasian.The procedure was a breast reconstruction.The deflation was confirmed through physical examination post procedure.The device was replaced with a silicone gel implant.The patient has fully recovered with no residual effects.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2019.Device evaluation summary: it was reported that a 56-year-old female had an 850cc artoura breast tissue expander implanted and that the tissue expander failed.This is indicative of deflation.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.The mentor product analysis lab discovered three rents.Rent a measuring approximately 1.8 cm, rent b measuring approximately 0.8cm, and rent c measuring approximately 0.3cm.All rents are located on the anterior aspect.Microscopic examination of the edges of the rents found two of them, a and c, revealed parallel striations.No other anomalies were discovered.The complaint was confirmed since a rupture was found in the device.Microscopic examination revealed parallel striations.This type of striation is more conclusive to sharp instrument damage rather than shell failure due to wear.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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: 8186496
• Report Number: 1645337-2018-07494
• Device Sequence Number: 19553072
• Product Code: LCJ
• UDI-Device Identifier: 00081317009573
• UDI-Public: 00081317009573
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2018

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: 04/17/2022
• Device Catalogue Number: TEXP140RUH
• Device Lot Number: 7568544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 01/22/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/15/2019; 01/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR