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

Model Number	SMXP140RH
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); Cancer (3262)
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.Since no lot number was provided, no manufacturing record evaluation could be performed.(b)(4).Reason for device explant and/or reoperation: neoplasm malignant.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast reconstruction with an artoura breast tissue expander 600cc and experienced malignant neoplasm on the right side post-operatively.As a result, the patient underwent removal and replacement with unspecified breast implants on (b)(6) 2020.This device was used in an off-label manner.Per the ifu, this device is not intended for use beyond six months.
Additional Manufacturer Narrative
Device evaluation summary: during the visual evaluation of the device, two tears were observed on the anterior view.Tear a measuring approximately 1.1 cm and tear b measuring approximately 0.8 cm.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After clinical review of the file on (b)(6) 2020, it was determined that the patient underwent implantation of the tissue expander as part of a reconstruction surgery post-mastectomy secondary to breast cancer.Upon successful expansion of the patient's breast tissue, the permanent breast implant was placed.With the information available at this time, there appears to be no alleged complaint relating to the identity, quality, durability, reliability, usability, safety, effectiveness, or performance of the mentioned devices.Patient code 3262 (cancer) is no longer applicable and has been updated to 2199 (no consequences or impact to patient).The device was used in an off-label manner; however, there is no evidence of any patient consequences resulting from the usage of the device.In addition, the customer has stated there were no device issues.If additional information is received, a supplemental report will be submitted.Reason for device explant and/or reoperation: successful expansion of breast tissue/replacement with permanent breast implant manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 20 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.The lot number was identified as 7711997.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.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: 10635749
• Report Number: 1645337-2020-12602
• Device Sequence Number: 19596718
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: SMXP140RH
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 7711997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 10/20/2020; 11/11/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/06/2020; 11/09/2020; 11/12/2020
• 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