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

Model Number	SDC130UH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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.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: as of now there is no information regarding the explant or reoperation.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent breast surgery with 650cc mentor artoura plus, smooth, ultra high profile and experienced expander deflation on her left side.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On april 24, 2023, 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.Per paperwork received with the device, following information has been updated on this form: is required intervention has been selected under section b; field b2.Fields d6b for explantation date have been updated to (b)(6) 2023.Field h6 health effect impact code ¿device explantation¿ has been added.Reason for device explant and/or reoperation: left deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 22, 2023, mentor completed a visual inspection, microscopic examination, and thickness measurement of the returned device.Device evaluation summary: visual analysis of the returned sample revealed that the tissue expander was found to have a tear between the shell and the anterior patch within a crease/ fold.A microscopic examination was performed and no instrument damage was observed at the edges of the rupture.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the tissue expander is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.Based on the implantation and explantation dates provided, it was noticed that the device was inside the patient for more than six (6) months.Per mentor instructions for use (ifu), tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off-label manner.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: 16700280
• Report Number: 1645337-2023-03731
• Device Sequence Number: 14369168
• Product Code: LCJ
• UDI-Device Identifier: 10081317028229
• UDI-Public: 10081317028229
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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 Expiration Date: 07/11/2025
• Device Model Number: SDC130UH
• Device Catalogue Number: SDC130UH
• Device Lot Number: 9598129
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 05/22/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/15/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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 Sex: Female