MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT; EXPANDER, SKIN, INFLATABLE

Model Number	3549336
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	11/02/2021
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 (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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast reconstruction revision with mentor cpx4 with suture tabs, tall height 1445cc and experienced deflation on the left side post-operatively.As a result, the patient underwent removal on (b)(6) 2021.
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the cpx4 th 1445cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the anterior view, measuring approximately 0.2 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander.Based on the information currently available, microscopic examination of the returned product indicates that the tissue expander could have been damaged during or subsequent to implantation.The product insert data sheet cautions to 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 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 CPX4 WITH SUTURE TABS, TALL HEIGHT
• 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: 12969538
• Report Number: 1645337-2021-13716
• Device Sequence Number: 14595611
• Product Code: LCJ
• UDI-Device Identifier: 00081317009757
• UDI-Public: 00081317009757
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/11/2021

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: 05/20/2024
• Device Model Number: 3549336
• Device Catalogue Number: 3549336
• Device Lot Number: 9448271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White