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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section e 1.Initial reporter phone: (b)(6).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: n/a.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 breast reconstruction with a 550cc mentor tissue expander on an unspecified breast.Post-operatively, the patient suffered breast implant deflation, during the third expansion session.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On february 17, 2025, 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 the return of the device, it is assumed that the patient underwent breast implant removal surgery on an unspecified date.Reason for device explant and/or reoperation: material rupture.
Additional Manufacturer Narrative
On may 20, 2025, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned device revealed that the exp rnd remote 550cc tissue expander was found to have a tear on the posterior view, between the union of the shell and the base, at 3 o¿clock.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 were identified.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.According to the manufacturing investigation, potential process failures resulting in possible leakage failure that may represent deflation/rupture were assessed concerning the product complaint.The process controls and data records collected for the deflated tissue expander are within specification.Therefore, the tears reported on the product are not able to be confirmed as manufacturing-related 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 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.No corrective and preventive action (capa) is required now.

• 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: 20518895
• Report Number: 1645337-2024-12461
• Device Sequence Number: 7880970
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: (01)00081317002437(17)271105(10)9979009
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,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: 9979009
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 02/17/2025; 05/20/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 03/09/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: Other; Required Intervention
• Patient Sex: Female