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	Deformity/ Disfigurement (2360)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) black female patient underwent a breast surgery with a 850cc artoura breast tissue expander and experienced a deflation on the left side post-operatively.As a result, the patient underwent explantation on (b)(6) 2022.
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: deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 14, 2022, the evaluation for the device was completed.Device evaluation summary: 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.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 the authorization form for examination was not received, the product evaluation lab couldn´t identify a conclusion due to the specific nature of this deflation.The evaluation was limited to non-destructive testing.Potential cause: while deflation is historically the most common complication related to tissue expanders, the rate of deflation with mentor® tissue expanders remains very low.An incident of this nature may be the result of one or more of the following factors: over-inflation of the tissue expander, use of the tissue expander in emerging surgical techniques not identified in the instructions for use (ifu), continuous and sustained stresses to the tissue expander, vigorous body movement (e.G.Physical exercise) or excessive manipulation/ trauma in the region of the expander.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.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 13966703
• Report Number: 1645337-2022-03572
• Device Sequence Number: 4186322
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 01/24/2024
• Device Model Number: SMXP155RH
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 9421082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American