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

Catalog Number	SDC130UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.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, a tear was observed between the union of the shell and the bladder.In addition, the device was received painted in blue.A microscopic examination was performed and the cause of the deflation could not be identified.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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).
Additional Manufacturer Narrative
On 22-feb-2024, 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
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.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast reconstruction procedure with a mentor artoura plus, smooth, ultra high profile 650cc tissue expander that deflated post implantation.Deflation of the patient¿s left breast tissue expander was reported.As a result, the patient underwent explantation and replacement with a mentor artoura plus, smooth, ultra high profile 650cc tissue expander on (b)(6) 2024.
Additional Manufacturer Narrative
On 02-may-2024, mentor re-evaluated the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.The product was returned to mentor for evaluation.Mentor conducted a visual inspection, microscopic examination, and shell thickness of the returned device.During visual analysis of the returned sample, a tear was observed between the union of the shell and the bladder.In addition, the device was stained blue.Microscopic examination was performed, and the cause of the tear could not be identified.Therefore, a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.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, ULTRA 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: 18656016
• Report Number: 1645337-2024-01397
• Device Sequence Number: 12561423
• Product Code: LCJ
• UDI-Device Identifier: 10081317028229
• UDI-Public: 10081317028229
• 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: 2024
• 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 Catalogue Number: SDC130UH
• Device Lot Number: 9917933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 03/20/2024; 05/02/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/08/2024; 03/21/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female