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

Catalog Number	SMXP130RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/03/2019
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 device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female underwent primary breast reconstruction with a 650cc artoura breast tissue expander and experienced left sided deflation on an unknown date post procedure.As a result, the explant and replacement with another 650cc artoura breast tissue expander was performed on (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 3/27/2019.Device evaluation summary: it was reported that a caucasian female underwent primary breast reconstruction with a 650cc artoura breast tissue expander and experienced left sided deflation on an unknown date post procedure.Upon receipt by mentor the device contained no fluid.Brown material was observed within the device and no foreign material was observed on the shell surface.During the initial evaluation the device appeared intact.No anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the mentor product analysis lab was precluded from further evaluating the device to avoid the compromise the device integrity.No other anomalies were observed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.The mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was not confirmed.At this time is not possible to determine the origin of the brown material observed on the received device.Because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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).
Additional Manufacturer Narrative
Additional information was received on 2/12/2019.The event was noted when trying to refill the expander 4-6 weeks post implantation.The event date and patient's age at the time of the event were obtained.The patient fully recovered from the replacement surgery.A manufacturing record evaluation (mre) was performed for the finished device number 7614522 on 2/26/2019, and no non-conformances related to the reported complaint condition were identified.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: 8355047
• Report Number: 1645337-2019-08713
• Device Sequence Number: 1973790
• Product Code: LCJ
• UDI-Device Identifier: 00081317024392
• UDI-Public: 00081317024392
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

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: 08/26/2022
• Device Catalogue Number: SMXP130RUH
• Device Lot Number: 7614522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 03/27/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/12/2019; 03/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR