MAUDE Adverse Event Report: MENTOR TEXAS MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Catalog Number	SDC150H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the tissue expander appears deflated.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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 patient implanted with two unspecified mentor tissue expanders experienced bilateral deflations post-operatively.As a result, the patient underwent explantation on (b)(6) 2023.This report is for the left side device.
Additional Manufacturer Narrative
On march 12, 2024, mentor received updated dates of implant and serial numbers for the devices.Relevant fields have been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received confirmed the patient's unspecified devices as 750cc mentor artoura plus, smooth, high profile tissue expanders.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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.During visual analysis of the returned sample artoura plus sm te hp 750cc a tear was observed between the union of the shell and the bladder.A microscopic examination was performed and the cause of the deflation could not be identified.Based on the information currently available.This product was sent to mentor's manufacturing team for additional analysis.According to the manufacturing investigation, the collected process controls and data records for the deflated tissue expander meet specifications.The tear mentioned in product complaint cannot be conclusively confirmed as a manufacturing defect.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of tissue expanders include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE
• 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: 18133570
• Report Number: 1645337-2023-13506
• Device Sequence Number: 6349164
• Product Code: LCJ
• UDI-Device Identifier: 10081317028274
• UDI-Public: 10081317028274
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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 Expiration Date: 08/03/2026
• Device Catalogue Number: SDC150H
• Device Lot Number: 9735862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 03/12/2024; 04/08/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 03/04/2024; 04/08/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic