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 Codes	Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	10/30/2020
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: tissue expander deflation, seroma, cellulitis.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction procedure with an artoura breast tissue expander 850cc device that deflated after implantation.The patient noticed a leak in her left breast tissue expander on (b)(6) 2020.In addition, the patient developed a seroma with early onset cellulitis in her left breast.A seroma catheter was placed to drain the seroma on (b)(6) 2020 which may have punctured the tissue expander.A culture was collected of the seroma fluid and it was sent to pathology for testing.Pathology results showed no growth.As a result, the patient underwent explantation and replacement with an artoura breast tissue expander 850cc device on (b)(6) 2020.

• 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: 11098418
• Report Number: 1645337-2020-16549
• Device Sequence Number: 19007890
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 07/19/2024
• Device Model Number: SMXP155RH
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 9473946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/30/2020
• 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: 54 YR