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

Catalog Number	SMXP140RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/12/2019
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) female patient underwent a breast reconstruction revision with mentor artoura breast tissue expander implants which the left side deflated after implantation.The issue was confirmed by the physician.As a result patient had the implant removed on (b)(6) 2019.
Additional Manufacturer Narrative
Device photos evaluation: during visual evaluation of the device it was observed a tear in one of the suture tab, measuring approximately 0.5 cm.Microscopic examination was performed to the rupture and no evidence of instrument damage was observed.No additional anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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.Although the manufacturing criteria was met during manufacturing, there is an open investigation to address with the defects of the suture tabs on the tissue expander as seen by the customer.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated device evaluation: during visual evaluation of the device it was observed a tear in one of the suture tab located at 9 o' clock.Microscopic examination was performed to the rupture and no evidence of instrument damage was observed.No additional anomalies were observed.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.Although the manufacturing criteria was met during manufacturing, there is an open investigation to address with the defects of the suture tabs on the tissue expander as seen by the customer.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, mentor became aware that on submission of manufacturer report number 1645337-2019-25792 has error on type of evaluation indicating is photo which the correct type is device evaluation.And h3 is yes.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: 9481753
• Report Number: 1645337-2019-25792
• Device Sequence Number: 2313147
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• 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
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/21/2019

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: 08/04/2023
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 7756746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 01/16/2020; 01/17/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/16/2020; 01/16/2020; 01/17/2020
• 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
• Patient Age: 53 YR