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

Model Number 9750CM23A

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards field clinical specialist (fcs), during a transcatheter aortic valve replacement case by transfemoral approach, the first sapien 3 ultra valve was unable to deploy as it appeared fluid would not make it through the lumen to inflate the balloon.This patient had very difficult access that required ballooning both illiac vessels and the distal aorta.Large bore 14fr sheaths were inserted on both sides and the left was chosen for the commander and sapien 3 ultra valve.The valve would not initially cross due to calcified valve and tortuous aorta.The commander was pulled back into the ascending aorta while the pigtail catheter was advanced to the left ventricle to use for a balloon aortic valvuloplasty (bav).A bav was performed with a 14mm balloon, and the sapien 3 ultra was then able to cross the valve.The physician noted difficulty pulling the flex catheter back and used significant force.Per the fcs, the physician was incorrectly pulling the balloon catheter back rather than the flex catheter.After properly pulling back the flex catheter, they went to deploy but the commander balloon did not inflate.It was then noticed there was damage to the balloon catheter, and it was leaking the fluid on the table.The sapien 3 ultra, commander, and esheath+ were all withdrawn.They were able to get the valve back into the sheath when they all exited the body.A new commander, esheath, and sapien 3 ultra valve were opened, and the valve successfully deployed.

Manufacturer Narrative

Updated sections d9, h3, and h6- type of investigation, findings, and conclusions.The returned device was visually evaluated, and the following was observed: kink on the balloon shaft at the warning marker.Bent nosecone.X-ray images were taken of the handle and damage on the balloon shaft was observed proximal to the stop sleeve and positioned proximally to the seal in the spine of the handle.During pre-decontamination evaluation, leakage was observed through the guidewire lumen at the y connector when inflating through the inflation balloon port.As observed from the x-rays, the leakage originates from the twist damage found on the balloon shaft proximal to the stop sleeve.Although the balloon shaft is reinforced with a wire braiding, forces such as tension, compression or torquing the material can compromise the balloon shaft walls and result in a leak path during inflation.The complaint for the inability to cross the native annulus was unable to be confirmed as no applicable imagery was provided while delivery system leakage was confirmed based on the evaluation of the returned device.No manufacturing non-conformances were identified during engineering evaluation.A review of the device history record, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the instructions for use and training manuals revealed no deficiencies.As the event description stated, "the valve would not initially cross due to calcified valve and tortuous aorta", it is possible that a calcified and tortuous aorta can create a challenging pathway for delivery system advancement through the vasculature, obstructing the valve crossing and resulting in the reported difficulty crossing the native annulus.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the inability to cross the native annulus.Evaluation of the returned delivery system revealed a balloon shaft damage/twist proximal to the balloon shaft stop sleeve.As observed from the x-rays, the leakage originates from the damage/twist found on the balloon shaft proximal to the stop sleeve.Although the balloon shaft is reinforced with a wire braiding, forces such as tension, compression or torquing the material can compromise the balloon shaft walls and result in a leak path during inflation.As the delivery systems are 100% tested for leakage, and the issue was undetected during preparation, it is likely that damage to the delivery system occurred during the procedure.Although there was no reported tracking or valve alignment difficulties in this case, the damage/twist seen on balloon shaft indicates that the device has been excessively manipulated.As such, available information suggests that procedural factors (excessive manipulation) may have contributed to the delivery system leakage.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 18487075
• MDR Text Key: 333024241
• Report Number: 2015691-2024-00265
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)250918(10)65289338
• 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: 03/18/2024

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: 9750CM23A
• Device Catalogue Number: N/A
• Device Lot Number: 65289338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• 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