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

Model Number	SMXP150RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/09/2021
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 (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).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent a primary breast reconstruction with 750cc artoura breast tissue expanders experienced bilateral expander deflation postoperatively.Deflation was diagnosed by physical examination.As a result, the patient underwent explantation and replacement with 790cc mentor memorygel breast implants, catalog # shpx790, left lot-serial # (b)(4) and right lot-serial # (b)(4) on (b)(6) 2021.This medwatch report is for the left-sided implant.
Additional Manufacturer Narrative
The mentor failure analysis lab has completed the evaluation of the suspect medical device.Device evaluation summary: upon receipt of the device at our analysis laboratory on (b)(6) 2021, we began an investigation to see if we could determine the root cause of the deflation.That investigation included a review of the manufacturing records for lot-7598735, and a visual evaluation of the device.During visual evaluation of the tissue expander, the tear was not identified.As a result, leak testing was performed in accordance with mentor procedures, and a tear was identified at 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.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.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.A manufacturing record evaluation was performed for the finished device 7598735 number, and no non-conformances were identified.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: 11611944
• Report Number: 1645337-2021-03592
• Device Sequence Number: 14275850
• Product Code: LCJ
• UDI-Device Identifier: 00081317024347
• UDI-Public: 00081317024347
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 06/20/2022
• Device Model Number: SMXP150RH
• Device Catalogue Number: SMXP150RH
• Device Lot Number: 7598735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/25/2021
• Initial Report FDA Received Date: 04/04/2021
• Supplement Report FDA Received Date: 05/09/2021
• 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: 38 YR