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

Model Number	3549216
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/23/2021
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: left deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent revision breast reconstruction with a 800cc mentor cpx 4 breast tissue expander with suture tabs and experienced expander deflation on her left side postoperatively.The patient underwent bilateral explantation and replacement with catalog number 3341457; serial number (b)(4) on the left side, and with catalog number 3341457; serial number (b)(4) on the right side on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021, expander evaluation was completed.Device evaluation summary: mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the med height te w/sut tabs 800cc returned device.Leak testing was performed in accordance with mentor's procedures.Findings revealed a tear at the juncture of the shell and the posterior patch.Microscopic examination was performed and the cause of the deflation could not be identified.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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 2, 2021, mentor received confirmation that for this patient the 1st tissue expander was placed (b)(6) 2021.Hence, after clinical/secondary review of this file performed on november 15, 2021, device problem code off-label use was added to more accurately report the off label use of expander.On november 15, 2021, device re-evaluation was completed and summarized as below: mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the med height te w/sut tabs 800cc returned device.Leak testing was performed in accordance with mentor's procedures.Findings revealed a tear at the juncture of the shell and the posterior patch.Microscopic examination was performed and the cause of the deflation could not be identified.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.Based on the implantation date provided and the expiration date of the reported lot number, the compliant device was implanted after its sterility expiration date.Per the product insert data sheet, sterility cannot be guaranteed if the packaging has been damaged or after the ¿use by date¿ shown on the box label.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• 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: 12660461
• Report Number: 1645337-2021-11551
• Device Sequence Number: 17356513
• Product Code: LCJ
• UDI-Device Identifier: 00081317006763
• UDI-Public: 00081317006763
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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: 03/09/2021
• Device Model Number: 3549216
• Device Catalogue Number: 3549216
• Device Lot Number: 7435918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 11/02/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 10/27/2021; 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2017
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White