MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Model Number	3549314
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
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 (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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with implantation of a 550cc mentor cpx 4 breast tissue expander with suture tabs.Post-operatively, the patient was concerned that the tissue expanders have been implanted for two years due to delayed explantation surgeries from covid.She also stated she was experiencing pain in her chest area while gardening.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Per the instructions for use, mentor cpx 4 breast tissue expander with suture tabs are not intended for use over 6 months, and thus this device is used in a manner inconsistent with the ifu.Refer to manufacturing report number 1645337-2022-01814 for the contralateral event.
Additional Manufacturer Narrative
On august 02, 2022, upon review, mentor regulatory/clinical safety departments determined that the device was not used off label.However, because there is still a user error component as the ifu states that these devices are intended for temporary implantation up to six months.H6 medical device problem code has been updated to use of device problem as it is more appropriate code than off label use.Manufacturer¿s reference number: (b)(4).In the initial, h6 medical device problem code should have been use of device problem instead of off label use as it is a more appropriate code.The ifu states that these devices are intended for temporary implantation up to six months.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13578791
• Report Number: 1645337-2022-01815
• Device Sequence Number: 11864691
• Product Code: LCJ
• UDI-Device Identifier: 00081317006800
• UDI-Public: 00081317006800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 3549314
• Device Catalogue Number: 3549314
• Device Lot Number: 7750200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2019
• 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