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

Model Number	SMXP155RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon visual evaluation of the video provided in the complaint, the implant was observed deflated.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: left expander deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient of an unknown age, race, and ethnicity underwent unspecified breast surgery with a 850cc artoura breast tissue expander and experienced left side expander deflation postoperatively.As a result, the expander was explanted on (b)(6) 2020.
Additional Manufacturer Narrative
On october 2, 2020, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, photo/video evaluation was completed, and on (b)(6) 2020, device evaluation was completed.Device evaluation summary: upon visual evaluation of the video provided in the complaint, the implant was observed deflated.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.No leak test was necessary to determine the location of the tear as we observed a tear at the union between the shell and the suture tab in the 6 o¿clock position.Additionally, the shell of the device was observed with a blue coloration.Per response received from the healthcare professional, blue color is dyed saline to help recognize a leak.When evaluated under a microscope the tear pattern did not reveal parallel striations that are consistent with markings made by a sharp instrument.The results also confirmed that there were no abnormalities with the manufacturing of the tissue expander that would have impacted its performance.Therefore, we were unable to identify the root cause of this tear.As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection since this could compromise the product integrity.We would like to assure you that mentor adheres to the highest standards of quality.Our quality assurance process is robust for every product we make and requires that each mentor product undergoes a stringent visual inspection and rigorous testing prior to shipment.In addition, we maintain a comprehensive quality assurance system that complies with the food and drug administration's (fda) good manufacturing practice regulations.Prior to shipping, our devices are checked to ensure that they satisfy these standards in accordance with these processes.We also closely and continually monitor and review the clinical performance and real-world evidence for all of our products through clinical studies, registries and post-market surveillance activities.At mentor, we are committed to delivering high-quality tissue expanders and an exceptional customer experience.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: 10505401
• Report Number: 1645337-2020-11163
• Device Sequence Number: 1218062
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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: 02/10/2023
• Device Model Number: SMXP155RH
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7680126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 10/23/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/07/2020; 10/27/2020
• 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: 49 YR