MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM29A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-01340.Complaint reference number: (b)(4).The investigation is ongoing.The device was not returned.

Event Description

As reported by a field clinical specialist (fcs), it was an off-label procedure of a 29 mm sapien 3 ultra resilia valve in the tricuspid position in an ew surgical valve via transfemoral approach.Post valve deployment, it was decided to "fracture" the existing surgical valve which resulted in wide open regurgitation.A 2nd 29 mm s3ur was implanted however, while deploying the 2nd 29 mm s3ur, the balloon on commander delivery system had a small hole resulting in multiple refills to deploy the valve.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed as no imagery was provided and no device was returned for evaluation.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Per event description, ''while deploying the 2nd 29 mm s3ur, the balloon on commander delivery system had a small hole resulting in multiple refills to deploy the valve''.During manufacturing balloons are 100% visually inspected at several different steps and devices are 100% leak tested.Therefore, it is unlikely that the delivery system left the manufacturing site with balloon damage.Additionally, there was no note of abnormalities or leakage on the delivery system during device preparation and de-airing, suggesting that there was no issue with the device when removed from packaging.As the medical records revealed that the team deployed the valve inside the pre-existing two valves, it is possible that the balloon interacted with the pre-existing valve during deployment, puncturing the balloon and resulting in the reported balloon leakage.As such, available information suggests that patient factors (pre-existing valve) may have contributed to the reported event.However, a definitive root cause was unable to be determined.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18785070
• MDR Text Key: 336622112
• Report Number: 2015691-2024-01352
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female