MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9000TFX23

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 04/21/2014

Event Type  Injury  

Event Description

During the transaortic tavr procedure, the first 23mm sapien valve was deployed in a 50:50 position, however, the patient¿s blood pressure remained in the 60's.A post deployment echocardiogram showed the patient had severe ai due to one of the sapien leaflets sticking in an open position.The decision was made to deploy a second valve.A second 23mm sapien valve was placed and deployed in a 60:40 a/v position with a final result of trace ai.The patient's pressure recovered to the 120's.The patient was in stable condition at the end of the procedure.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Per report, the aortic valve and root were severely calcified, the ejection fraction was 58%, the sinotubular junction (stj) measured 23.2mm, the sinus of valsalva (sov) measured 24.5mm, the patient had a porcelain aorta and the patient did not have severe ventricular septal hypertrophy or mitral annular calcification (mac).Additionally, both the image intensifier angle and the coaxial alignment of the delivery system and valve were noted to be good, ventilation was held and there was no loss of pacing capture during valve deployment.Cine and echo images were submitted to edwards for review.The following observations/impressions were made: the patient had severe aortic valve calcification on the non-coronary cusp (ncc) and right coronary cusp (rcc), severe aortic root calcification, a porcelain aorta, and severe mac.The tao sheath was in place too deep.There was fair coaxial alignment of the sheath, wire and delivery system.The image intensifier angle (iia) was good.The valve was positioned slightly aortic prior to deployment.Post deployment the valve appeared to be approximately 45:55 aortic/ventricular at the left coronary cusp (lcc), unable to view the position in the ncc.The valve appeared to be slightly under-expanded.The second valve was deployed 1 stent strut more aortic (3-4mm higher) than the first valve.On short axis view the lcc and rcc were noted to be moving, however, the ncc was not able to be visualized.Impressions: the valve was slightly ventricular and under-expanded, resulting in central ai.The cause of the non-functioning leaflet cannot be determined on the images provided.The device is not available for evaluation as it remains implanted in the patient.Per the instructions for use, valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning leaflet.Based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with native leaflet overhang.Other potential contributing factors include: leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Occasionally there are cases where the root cause of the non-functioning leaflet cannot be determined.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, per the imaging review, the cause of the non functioning leaflet could not be confirmed.The valve was positioned slightly ventricular and under-expanded which subsequently resulted in central ai.The ifu 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 preventative actions are required.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3813008
• MDR Text Key: 4529051
• Report Number: 2015691-2014-01147
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2016
• Device Model Number: 9000TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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: 87 YR
• Patient Weight: 63