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

Model Number	3504311M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Code Available (3191); Insufficient Information (4580)
Date of Event	11/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient who had a 700cc mentor tissue expander experienced deflation on an unknown side post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.No additional information is available at this time, if additional information is made available in the future, then a supplemental report will be submitted.
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device 7421764 number, and no non-conformance's related to the malfunction were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on (b)(6) 2020.The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2020.Device evaluation summary: according to the information provided, the patient experienced a deflation of the tissue exapnder.During visual evaluation of the sample a tear was discovered at the union between the patch and shell of the tissue expander.Microscopic examination of the edges of the rupture revealed parallel striations consistent with a rupture with a sharp object.The striations are consistent with markings made by a sharp instrument perforating silicone material.As stated in the product insert data sheet, do not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures as this can result in rupture.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).
Additional Manufacturer Narrative
Upon review, mentor has determined that the type of procedure has been reported incorrectly.This device was being used in skin laceration repair procedure.Additionally, since the device was returned for analysis, there device must have been explanted.The date of explant was not provided.The appropriate fields have been updated.Manufacturer's reference number: (b)(4) updated procedure type, described in section h10.Health effect - impact code device explantation (f1903) added to section h6, and checked b2 required intervention.
Additional Manufacturer Narrative
Manufacturer¿s reference number: (b)(4), an incorrect patient code (3191 ¿ no code available) was used for this event.The correct code has been added.Mentor became aware of this on (b)(6) 2021.H6 health effect - clinical code: e2401 "insufficient information.".

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9521712
• Report Number: 1645337-2019-26170
• Device Sequence Number: 10877390
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 3504311M
• Device Catalogue Number: 3504311M
• Device Lot Number: 7421764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/24/2020; 02/08/2020; 07/16/2021; 07/28/2021
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/27/2020; 02/19/2020; 07/16/2021; 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention