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

Model Number 9600LDS26

Device Problems Kinked (1339); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

Additional potential risks associated with the tavr procedure, the bioprosthesis, and the use of its associated devices and accessories include valve deployment in unintended location.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes patient screening, device preparation, approach, deployment, imaging, proper guidewire positioning, careful manipulation of devices, procedure-specific training manuals and proctored procedures.Per the ifu, ¿advance the delivery system until the thv exits the sheath.Retract the loader to the proximal end of the delivery system.Caution: the thv should not be advanced through the sheath if the sheath tip is not past the aortic bifurcation to minimize the risk of damage to the iliac vessel(s).¿ there may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.Although, generally well tolerated, the long term effects are not completely understood.In this case, the cause of the withdraw difficulties and sub sequent device placement at incorrect location was due to device manipulation.The back wire was not held tight as the delivery system was advanced through the esheath causing a loop in the wire.No actual device malfunctions were identified in the report.The ifu and edwards thv patient screening and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventive actions are required.

Event Description

During advancement of the valve through the esheath, the back wire was not maintained and moved forward with the delivery system.The wire then created a loop just outside the esheath.The wire loop was not noticed as the imaging was focused on the end of the wire in the lv.As the physician was advancing the valve out of the sheath, increase resistance was felt.Under fluro, it appeared the balloon part of catheter followed the wire loop and kinked causing the valve to be at a 45 degree angle.The delivery system was then pulled back into the esheath to straighten the wire out and the valve caught on the sheath causing the proximal portion of the valve to expand.Access was then obtained in the left radial artery and a snare was used to pulled the wire and straighten the system.The valve was then advanced to the descending aorta, where it was deployed.A second valve was implanted in the native annulus in an 80/20 aortic/ventricular position without paravalvular leak (pvl).The patient tolerated the procedure well.

• 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 (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 6672755
• MDR Text Key: 78563355
• Report Number: 2015691-2017-01875
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• 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: 75 YR