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

Catalog Number	3504311M
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
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.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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a mentor tissue expander 700cc being used in a breast reconstruction was found to be unable to be inflated during the operation.The surgery was reportedly prolonged 90 minutes.The surgeon used backup devices, and the surgery was completed.No other adverse events were reportedly experienced by the patient.
Additional Manufacturer Narrative
On mar 18, 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 and leak testing of the returned device.During a visual evaluation, no apparent damage or visual anomalies were observed on the exp rect remote 700cc returned device.Leak testing was performed on the injection reservoir, according to mentor procedure, and it presents difficulty with extracting and dosing the expansion fluid.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.According to the manufacturing investigation, the process controls and data records collected for the exp rect remote 700cc are within specification.In addition, the inspection performed provided evidence that the device was not occluded and was inflated without any difficulty.Therefore, based on the manufacturing records and the inspection performed, occlusion in tubbing defect reported on product complaint is not able to be confirmed as manufacturing defect.An awareness training will be provided to manufacturing associates to inform them of this complaint and reinforce the current process controls.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturing records were reviewed to determine if lot number 9725077 was associated with nonconformances and to identify devices rejected in-process for defects similar to the difficulty with expansion fluid removal reported in the complaint.The lot was associated with a nonconformance.However is not related to issue found.Additionally, no devices were rejected in-process for occlusion - tubing (oltu).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: 18818097
• Report Number: 1645337-2024-02606
• Device Sequence Number: 14525408
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 06/15/2026
• Device Catalogue Number: 3504311M
• Device Lot Number: 9725077
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/18/2024; 06/24/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/08/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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: Other
• Patient Sex: Female