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

Model Number 9750CM29A

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2024

Event Type  Injury  

Event Description

As reported by the field clinical specialist, during a right transfemoral tavr procedure, the first 29 mm sapien 3 ultra resilia (s3ur) valve embolized into aorta.The second valve, commander and esheath were opened and prepped.The second valve was deployed without any issues.Per report, the first system was prepped added 3cc's for deployment for annular area of 694mm2.A pre-bav was done with a 24mm zmed balloon.A 29 mm s3ur was delivered across the native annulus.Pacing and injection were performed, and they started to inflate the commander delivery system.It was noticed that the flex catheter had not been pulled back, however the balloon was already partially inflated on the ventricular side (maybe 20-30 %).An attempt was made to pull the flex catheter back, but the balloon catheter/bond broke and the partially expanded valve embolized into the aorta.The team pulled the valve aortic to secure/deploy the valve in the thoracic aorta.Resistance was noted when pulling the commander balloon out of the valve which was now positioned in the thoracic aorta.Serial ballooning (8mm,10mm, 12mm, 14mm) of the s3ur valve was then performed from the radial artery to help withdraw the commander balloon from the partially inflated s3ur valve.Once the commander was freed from the valve, the commander and sheath were removed as a unit and exchanged for a new 16f esheath.The aorta was measuring 24.5mm, so the 24mm zmed was used to fully deploy and secure the first 29mm valve in the thoracic aorta above the renal arteries.A second commander and 29mm s3ur valve were prepped per ifu.The second valve was inserted and deployed in the aortic annulus without any issues.There were good results per echo report.There was no paravalvular leak (pvl), low gradient and 80/20 aortic/ventricular positioning.The patient was extubated and awake and was discharged to recovery.

Manufacturer Narrative

Investigation is ongoing.This is one of two reports being submitted for this case.

Manufacturer Narrative

Additional information was added to h.6: device code the following observations were made during the pre-decontamination evaluation of the commander delivery system: the balloon shaft braiding was exposed past the warning marker.When flushing the device, a leakage was observed at the guidewire port and at the handle area near the exposed balloon shaft braiding.

Manufacturer Narrative

G6 and h2 were updated.Please reference manufacturer report number: 2015691 2024 00908.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18678730
• MDR Text Key: 335071516
• Report Number: 2015691-2024-00911
• 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,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Lot Number: 65238368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male