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

Model Number 9610TF23U

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

As reported from australia by our edwards lifesciences affiliate, the 23mm commander delivery system balloon inflated more slowly at the distal end than the proximal end during valve deployment.The patient was undergoing a transfemoral transcatheter aortic valve replacement procedure with a 23mm sapien 3 ultra valve.During the procedure, there was resistance during insertion of the commander delivery system through the 14fr esheath.Alignment was performed when the delivery system balloon was not completely outside of the esheath.The flex tip of the delivery system and the inflow of the transcatheter heart valve were sitting above the distal sheath tip.The clear plastic at the tip of the esheath was missing and was unable to be located under x-ray.During valve deployment, the inflation of the commander delivery system was slow at the distal side of the balloon.The valve was implanted successfully, and there was no patient injury.The patient went to ward after the procedure.

Manufacturer Narrative

Investigation is ongoing.

• 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: 18811352
• MDR Text Key: 336622830
• Report Number: 2015691-2024-01470
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Lot Number: 65053639
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2023
• 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