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

Catalog Number	SDC140UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast reconstruction primary with mentor artoura plus, smooth, ultra high profile tissue expanders and experienced deflation on the left side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent removal on (b)(6) 2024.
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.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.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 9, 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
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the artoura plus sm te uhp 850cc tissue expander.Leak testing was performed, according to mentor procedure, and it identified a tear at the union between the shell and the base.Microscopic examination was performed and the cause of the deflation could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the issue reported were 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 process controls, the evaluation performed, and the data records for the deflated tissue expander meet specifications.The tear mentioned in the product complaint cannot be 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: the silicone shell of the tissue expander may easily be cut by a scalpel or ruptured by excessive stress, manipulation with blunt instruments, or penetration by a needle.Subsequent deflation and/or rupture could result.All devices should be carefully inspected for structural integrity prior to and during implantation.In addition, the patient should be advised that vigorous body movement (e.G., physical exercise) or excessive manipulation or trauma in the expander region may cause stress to the device and result in subsequent deflation.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 20398537
• Report Number: 1645337-2024-11742
• Device Sequence Number: 20462399
• Product Code: LCJ
• UDI-Device Identifier: 10081317028281
• UDI-Public: (01)10081317028281(17)270512(10)9909423
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: SDC140UH
• Device Lot Number: 9909423
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 12/05/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/01/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White