MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA PLUS SMOOTH HIGH PROFILE 600CC; EXPANDER, SKIN, INFLATABLE

Model Number	SDC140H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
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: n/a manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 600cc artoura plus smooth high profile tissue expander deflation intra-operatively.As a result, the implant was replaced with an unspecified implant.There was no report of adverse event or patient consequence.
Additional Manufacturer Narrative
On september 4, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection leak testing and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the artoura plus smooth high profile 600cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and a tear was noted at the patch on the posterior view.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, a microscopic examination of the returned product indicates that the tissue expander could have been damaged during implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
On august 16, 2022, the mentor failure analysis lab 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.
Additional Manufacturer Narrative
On august 11, 2022, mentor became aware that the date of event was on june 16, 2022.

• Brand Name: ARTOURA PLUS SMOOTH HIGH PROFILE 600CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14958959
• Report Number: 1645337-2022-08036
• Device Sequence Number: 20571193
• Product Code: LCJ
• UDI-Device Identifier: 10081317028267
• UDI-Public: 10081317028267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2025
• Device Model Number: SDC140H
• Device Catalogue Number: SDC140H
• Device Lot Number: 9521098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 08/16/2022; 09/04/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/15/2022; 08/31/2022; 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown