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

Catalog Number 3504307M

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 01/31/2019

Event Type  Injury  

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 device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient had a 550cc mentor tissue expander implanted that the right sided expander could not be sufficiently filled with saline during the procedure.As a result, the device was replaced with another 550cc mentor tissue expander.

Manufacturer Narrative

The investigation of the returned device was completed by the failure analysis lab on 9/13/2019.Device evaluation summary: according to the reported information, the customer experienced difficulty adding or removing saline solution to the tissue expander during surgery.During evaluation of the device it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected, but difficulty with valve expansion occurred.The analysis was¿unable to determine the root cause for difficulty with fluid addition or removal due to the defective valve.Excessive manipulation may have caused the failure; however, this cannot be conclusively determined.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

A manufacturing record evaluation (mre) was performed for the finished device number 7412048 on 3/8/3019, and no non-conformance's related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

The mentor failure analysis lab received the device for evaluation on 8/5/2019.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Along with the device the serial number was obtained.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8401346
• MDR Text Key: 138153463
• Report Number: 1645337-2019-09070
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Catalogue Number: 3504307M
• Device Lot Number: 7412048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/08/2019; 08/05/2019; 09/13/2019
• Supplement Dates FDA Received: 04/01/2019; 08/30/2019; 09/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention