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

Catalog Number	TEXP120RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/02/2018
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.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.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an unknown breast reconstructive surgery with mentor artoura breast tissue expander 375cc which the left side deflated after implantation.As a result, patient had the device explanted on 8/29/2018.
Additional Manufacturer Narrative
On (b)(6) 2018 mentor lab evaluation report indicated: upon receipt by mentor, the device returned without fluid.Red and white material was observed within the device.Red material was observed on the shell surface.Mentor product analysis lab discovered a rent of 2 cm and other of 1.5 cm on the anterior aspect.No other anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage or the etiology of the red material found on the device.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.(b)(4).
Additional Manufacturer Narrative
On 10/02/2018, 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.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: 7891626
• Report Number: 1645337-2018-05667
• Device Sequence Number: 16825801
• Product Code: LCJ
• UDI-Device Identifier: 00081317009467
• UDI-Public: 00081317009467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2018

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: 06/26/2020
• Device Catalogue Number: TEXP120RH
• Device Lot Number: 7345418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 10/19/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/04/2018; 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention