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

Model Number 9000TFX23

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 01/13/2014

Event Type  Injury  

Event Description

As reported by the edwards field clinical specialist, during a transaortic tavr case the patient required two sapien valves due to moderate to severe central aortic insufficiency.Per report, the procedure went smoothly with no complications for the first valve delivery.The 23mm sapien valve crossed the native annulus and was placed 50:50; the valve was deployed 60:40 aortic.Echo findings post deployment showed no paravalvular leak, and moderate to severe central aortic insufficiency.After further investigation, the leaflet at the left coronary cusp seemed to not be closing.An attempt to free the frozen leaflet with a pigtail was unsuccessful.A second 23mm sapien valve was placed very slightly more aortic to hopefully correct any possible leaflet overhang that was preventing the leaflet from closing.The final result was zero central aortic insufficiency.The implant team was unable to determined the exact cause of this event, however possible causes included either a frozen leaflet or native leaflet overhang.Per information received during investigation of this event, the patient did well post tavr.There were no issues noted while prepping the first valve.There was no difficulty crimping the valve and the valve crimp was completed by an experienced edwards clinical specialist.Imaging for this case was provided and a review has been requested.Additional information: the native valve/leaflet calcification was described as moderate.There was no ventricular septal hypertrophy.Coaxial alignment of the delivery system and the valve was described as fair.The image intensifier angle was appropriate.There was no loss of pacing capture during valve deployment and ventilation was held.This patient¿s ejection fraction was 60 percent.

Manufacturer Narrative

Investigation of this event is ongoing.

Manufacturer Narrative

Echo images were submitted to edwards for review; cine was not provided.The imaging provided was reviewed by an edwards medical director.Observations/impression: observations: mild aortic valve calcification, mild aortic root calcification.Significant calcification on the left coronary cups (lcc) and non-coronary cusp (ncc) noted on the short axis view (sax) view.Post valve deployment, severe aortic regurgitation and non-functioning leaflet noted at the lcc.¿valve position appears 60:40 aortic.Impressions: based on tee, valve positioning is acceptable without evidence of native leaflet overhang, significant canting of the valve, or bulky calcification entrapping the leaflet.Subsequent valve in valve appears to have corrected the problem.The root cause of the non-functioning lcc remains undefined.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.In this case, the root cause for the non-functioning leaflet cannot be confirmed.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 have contributed to the event.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; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3620296
• MDR Text Key: 19567773
• Report Number: 2015691-2014-00282
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2014

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: 08/26/2014
• Device Model Number: 9000TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 02/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2012
• 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: 66 YR
• Patient Weight: 153