MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA PLUS SM TE UHP 535CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	SDC120UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 review could be performed.Reason for device explant and/or reoperation: na mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent a breast reconstruction primary with an unknown tissue expander, saline prosthesis experienced right-sided deflation postoperative.The patient reported that night after it was last filled, the right side was tight then released, felt a pocket of fluid between the breast and expander.The doctor confirmed the fluid was saline, and tissue expander deflated.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Additional information received on august 9, 2024 indicated that the suspect device identity is as follow: lot#: 9959184, cat: sdc120uh.Device was removed on (b)(6) 2024.Reason for device explant and/or reoperation: deflation.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA PLUS SM TE UHP 535CC
• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19924125
• Report Number: 1645337-2024-09180
• Device Sequence Number: 8113907
• Product Code: LCJ
• UDI-Device Identifier: 10081317028212
• UDI-Public: (01)10081317028212(11)230915(17)270912(10)9959184
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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 Catalogue Number: SDC120UH
• Device Lot Number: 9959184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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; Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White