MAUDE Adverse Event Report: MENTOR TEXAS EXP RECT REMOTE 250CC; EXPANDER, SKIN, INFLATABLE

Model Number	3504302M
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
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: 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 female patient underwent a breast augmentation with a exp rect remote 250cc and experienced a deflation on an unspecified side post-operatively.The device¿s use in a breast augmentation is considered off label use of the product.As a result, the patient underwent explantation, but a specific date was not provided.
Additional Manufacturer Narrative
On june 6, 2023, mentor completed evaluation of a returned photo of the device.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.On june 20, 2023, mentor received an updated dates of implant and explant.The device was confirmed to be the left side device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2023, mentor removed the off-label coding in the previously submitted report.Use of this device in a breast augmentation is acceptable within the published instructions for use.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 25, 2023, mentor completed evaluation of the device.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the exp rect remote 250cc breast implant was found to have a tear on the union between shell and patch.Microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.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, manufacturing records and processes including process controls collected and reviewed for the device are within specification.Rupture reported on product complaint is not able to be confirmed as manufacturing defect.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 27, 2023, mentor received an updated serial number, and dates of implant and explant.On july 14, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: EXP RECT REMOTE 250CC
• 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: 17039875
• Report Number: 1645337-2023-06440
• Device Sequence Number: 20560071
• Product Code: LCJ
• UDI-Device Identifier: 00081317002383
• UDI-Public: 00081317002383
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K842883
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 05/03/2026
• Device Model Number: 3504302M
• Device Catalogue Number: 3504302M
• Device Lot Number: 9724192
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 06/27/2023; 08/17/2023; 08/25/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/17/2023; 08/18/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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 Sex: Female