MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH; CPX4 BREAST TISSUE EXPANDER WITH SMOOTH SURFACE

Catalog Number	3509313
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 38-year-old female who underwent a breast reconstruction primary with a mentor cpx4 with suture tabs, tall height, smooth, 450cc saline prosthesis experienced right sided deflation post procedure.As a result, patient underwent removal on (b)(6) 2023.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: deflation.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
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.Per additional information received with the device indicated that the patient ethnicity is caucasian and date of event was on may 13, 2023.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on october 15, 2023: 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 a rupture at the bladder shell juncture on the anterior view of the tall height te smooth, 450cc tissue expander.Microscopic examination was performed and the cause of the tear could not be identified.As the authorization form for examination was not received, the product evaluation lab was limited to non-destructive testing, therefore, the shell thickness measurement was not performed.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.According to the manufacturing investigation, per procedures and as documented in the electronic device history record, the device was inspected for defects and leaks and was manufactured following normal processes.The complaint device lot was not related to a nonconformance, nor its related shell sub-assemblies, which were found compliant with the number of dips and viscosity specifications, therefore, this complaint cannot be confirmed as a manufacturing defect.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH
• Common Device Name: CPX4 BREAST TISSUE EXPANDER WITH SMOOTH SURFACE
• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17443467
• Report Number: 1645337-2023-09025
• Device Sequence Number: 2712587
• Product Code: LCJ
• UDI-Device Identifier: 00081317026723
• UDI-Public: 00081317026723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2023
• Device Catalogue Number: 3509313
• Device Lot Number: 7727833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 10/15/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/17/2023; 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White