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

Model Number	TEXP120RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2019
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: deflation.Concomitant medical products: mentor artoura breast tissue expander 375cc breast tissue expander, cat#:texp120rh, sn#: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast reconstruction primary with mentor artoura breast tissue expander 375cc breast tissue expander which the left side deflated after implantation.The issue was confirmed by the physician.As a result patient underwent bilateral removal and replacement as follow: left replced with catalog number shpx415 serial number (b)(4), and right replaced with catalog number shpx450, serial number (b)(4) on (b)(6) 2019.
Additional Manufacturer Narrative
Evaluation of the device received video: upon evidence found in video, this suggested that the device has some punctures and it was leaking.However, it does not provide enough evidence to determine any root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process, complaint trends for mentor devices will continue to be monitored by quality assurance.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).
Additional Manufacturer Narrative
Device evaluation completed on september 9 2020: upon evidence found in video, this suggested that the device has some punctures and it was leaking.However, it does not provide enough evidence to determine any root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process, complaint trends for mentor devices will continue to be monitored by quality assurance.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.,according to the information reported, a deflation occurred in a tissue expander.During the visual evaluation of the device, a tear was observed at the juncture of the shell and anterior patch.Leak testing was performed in accordance with mentor's procedures.There were no additional leak sites.Microscopic examination was performed and the cause of the rupture could not be identified.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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/rupture 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
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: 9341846
• Report Number: 1645337-2019-24111
• Device Sequence Number: 16690169
• Product Code: LCJ
• UDI-Device Identifier: 00081317009467
• UDI-Public: 00081317009467
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2019

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: 03/22/2023
• Device Model Number: TEXP120RH
• Device Catalogue Number: TEXP120RH
• Device Lot Number: 7701334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 08/14/2020; 09/09/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/18/2019; 08/24/2020; 09/10/2020
• 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