MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA SS, T EXP,UHP,650CC; EXPANDER, SKIN, INFLATABLE

Model Number	SMXP130RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
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 (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: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female who was going to have an unknown procedure with an artoura breast, 650cc, tissue expander experienced left sided deflation pre-implantation.The health care professional received an expander with a hole in it.No adverse event or patient consequences was reported.
Additional Manufacturer Narrative
Device evaluation completed on october 12, 2021: 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 ss, t exp,uhp,650cc tissue expander.Leak testing was performed in accordance with mentor procedures and a tear was found in the anterior aspect of the artoura ss, t exp,uhp,650cc tissue expander, measuring approximately 0.1 cm.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, microscopic examination of the returned product indicates that the tissue expander could have been damaged prior to implantation.The product insert data sheet cautions not to allow cautery devices or sharp instruments such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during implantation or other surgical procedures.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA SS, T EXP,UHP,650CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12507637
• Report Number: 1645337-2021-10527
• Device Sequence Number: 14742467
• Product Code: LCJ
• UDI-Device Identifier: 00081317024392
• UDI-Public: 00081317024392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/25/2021

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: 03/30/2025
• Device Model Number: SMXP130RUH
• Device Catalogue Number: SMXP130RUH
• Device Lot Number: 9556271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR