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

Model Number 9600LDS29

Device Problems Failure to Align (2522); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2021

Event Type  malfunction  

Event Description

Device was de air balloon, crimped the valve on the delivery system, when the delivery system was deploying the valve every time the doctor would manually use the lock the knob would not allow alignment with the balloon.Tried trouble shooting with the vendor but it still wouldn't work.The balloon would not fully move inside the valve.Tried to free the balloon but the balloon wouldn't move further towards the valve.The valve was unable to be deployed.The whole system was decided to be removed with the valve, but the valve seemed to be pulled back into the sheath.A femoral cut down was done to remove the valve, a new device with a different lot number was used and worked fine.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13541581
• MDR Text Key: 285673894
• Report Number: 13541581
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2021,12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 63947103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2021
• Event Location: Other
• Date Report to Manufacturer: 02/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 DA
• Patient Sex: Male