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

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.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.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old male patient underwent an unspecified reconstructive skin surgery with a 550 cc mentor smooth rectangle tissue expander that deflated postoperatively.The patient had successful inflation stages prior to the event, but during this stage, the device would not inflate further.As a result, surgical intervention was performed, where it was found that the device had deflated.It was explanted the same day, on (b)(6) 2020.There are no indications of any patient events or aesthetic failures prior to this deflation.
Additional Manufacturer Narrative
On 12/23/2020, mentor became aware that patient's serial number is (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2021.Device evaluation summary: according to the information received, the patient experienced a deflation in the exp rect remote 550cc tissue expander.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the exp rect remote 550cc tissue expander was found to have a tear at the union between shell and patch.Microscopic examination was performed and the cause of the tear could not be identified.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
• MDR Report Key: 11028367
• Report Number: 1645337-2020-16024
• Device Sequence Number: 11649668
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2020

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: 05/08/2023
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 7711996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 02/09/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/13/2021; 03/01/2021
• 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: Required Intervention
• Patient Age: 10 YR
• Patient Weight: 32