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

Model Number	SMXP135RUH
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a primary breast reconstruction with a 700cc artoura breast tissue expander and experienced postoperative left-sided deflation.The patient had a consultation on (b)(6) 2019, and the deflation was confirmed by a healthcare professional.Since the device was left in for over six months, it was used in a manner inconsistent with the product insert data sheet.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On 24-jul-2020, the suspected medical device was returned for evaluation.On 10-aug-2020, the investigation on the suspected medical device was completed.Investigation summary: no leak test was performed, since a tear was observed at the union between the shell and the suture tab in the 6 o¿clock position.When the device was evaluated under a microscope, the tear pattern did not appear to be 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, mentor was unable to identify the root cause of this tear.Based on the dates of implantation and explantation provided, it was noticed that the device was implanted inside of the patient for more than six months.Per mentor ifu, tissue expanders are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.Mentor's quality assurance process is robust for every product we make prior to shipping, each mentor device undergoes a stringent visual inspection and rigorous testing to ensure that the device meets the required specifications.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.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: 10226246
• Report Number: 1645337-2020-08139
• Device Sequence Number: 2880123
• Product Code: LCJ
• UDI-Device Identifier: 00081317024408
• UDI-Public: 00081317024408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 02/26/2023
• Device Model Number: SMXP135RUH
• Device Catalogue Number: SMXP135RUH
• Device Lot Number: 7684878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: 36 YR