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

Model Number 9750CM29A

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Difficult to Remove (1528); Device Slipped (1584); Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards field clinical specialist, during a transcatheter aortic valve replacement case by transfemoral approach, a 29mm sapien 3 ultra resilia valve was prepped according to the instructions for use (ifu) and handed to the team to insert into the 16fr esheath without issues.The patient's descending and abdominal aorta anatomy were tortuous.The implanting cardiologist was able to deliver the valve through the 16fr esheath+ without issues and placed the valve somewhere mid descending thoracic aorta to align the valve.It was noted that the team had to stop aligning the balloon into the valve because they reached the end of the fine adjustment wheel.The team unlocked the balloon and brought back the aligning tool to start the aligning process all over again.This was done twice before the valve was finally aligned between the makers on the balloon.When the team then advanced the delivery system over the arch, it was noted the balloon on the distal tip of the delivery system was very irregular and baggy.The valve was brought over the arch and placed across the valve.The pusher was then unlocked and brought back beyond the third maker.When this was done the 29mm valve jumped back proximally on the balloon.The team then brought the valve back to the pusher and brought the system back over the arch and tried to realign the valve once more.Once the system/valve was aligned again the team once more went over the arch and placed the 29mm valve through the native valve.Again, once they unlocked the pusher to bring it back the valve moved proximal on the balloon.The team decided this time to proceed and start the valve deployment with very gentle pressure on inflating the balloon.Rapid pacing started and the map was below 50mmhg.The team started to inflate the balloon, but nothing was happening.The team could see that the contrast was coming out around the 29mm valve, but the valve was not inflating.Pacing was stopped and it was determined that the balloon had torn from aligning.The valve and delivery system were brought back into the 16fr esheath+ without issues but got stuck was the non-expanding portion of the esheath+.The team then removed the delivery system, valve, and 16fr esheath+ all together as a single unit.A new 16fr esheath+ was opened and inserted into the patient without issues.Next, a new 29mm sapien 3 ultra resilia valve and delivery system were opened and prepped according to ifu.The team decided this time to align the valve more in the abdominal aorta.Alignment of the valve was done this time without running out of room on the small adjustment wheel.The valve was delivered over the native valve and deployed without leaks or issues.The delivery system was removed along with the 16fr esheath+.An angio runoff was performed which showed good blood flow and no vascular injury.The patient was sent to recovery in stable condition.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18328812
• MDR Text Key: 330936051
• Report Number: 2015691-2023-18378
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)250523(10)65331152
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Catalogue Number: N/A
• Device Lot Number: 65331152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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