MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3504307M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent breast reconstruction with a 550cc mentor tissue expander experienced deflation post operatively.As a result, explant was performed on an unknown date.
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on may 28, 2024.The explant and implant date were obtained with receipt of the device.The device was implanted on (b)(6) 2023.The explant was performed on (b)(6) 2024.The investigation of the returned device was completed by the failure analysis lab on june 5, 2024.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, microscopic examination, and shell thickness of the returned device.Visual analysis of the returned sample revealed that the tissue expander was found to have a tear on the posterior view, between the union of the shell and base.A 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.The patient should be advised that vigorous body movement (e.G., physical exercise) or excessive manipulation or trauma in the region of the expander 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.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 TISSUE EXPANDER
• 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: 19122417
• Report Number: 1645337-2024-04579
• Device Sequence Number: 12851911
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K842883
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 3504307M
• Device Lot Number: 9816439
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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