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

Model Number 9000TFX23A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Additional information provided by the hospital echocardiogram (tee) indicated that during deployment of the first sapien valve, ventilation was held with rapid pacing.Post deployment the valve appeared to be well seated, however by doppler there was evidence of at least moderate central ai and mild paravalvular leak (pvl) originating from the posterior aspect of the valve.Due to the image quality the prosthetic leaflets could not be adequately visualized and the decision was made to implant a second valve.A repeat echocardiogram showed there was no evidence of central ai and only trace pvl.The peak gradient across the valve was 11mmhg and the mean gradient across the valve was 5 mmhg.At the conclusion of the case, there was no evidence of pericardial effusion, left ventricular function was normal and appeared unchanged from baseline imaging.

Manufacturer Narrative

Additional information: per the instructions for use, device malposition requiring intervention and valve regurgitation are known potential adverse event associated with the tavr procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or severely calcified aortic leaflets, preserved ejection fraction, significant mitral annular calcification (mac), loss of pacing capture, and movement of the delivery system by the operator.Deployment of the sapien valve too aortic has the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency; it can obstruct the coronary ostia; and lead to embolization of the prosthesis into the ascending aorta.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, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for aortic malposition (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.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.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, based on the imaging report performed and the event report, the cause for the 70:30 aortic position and subsequent regurgitation can be most likely attributed to poor coaxial alignment of the sheath and poor intensifier angle.The possible flaring of the valve was attributed to the high placement of the valve.There was no indication or allegation of a device malfunction.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.

Event Description

As reported by the edwards field clinical specialist, during the transapical tavr procedure, the first 23mm sapien valve was deployed too high which resulted in paravalvular leak and a non functioning leaflet.Per report, the valve was flared during the inflation.A second 23 sapien valve was deployed within the first valve.The patient was in stable condition at the end of the procedure.The possible flaring of the valve was attributed to the high placement of the valve.

Manufacturer Narrative

Based on the information provided it is unknown which of the reported valves was implanted first; therefore the information pertaining to both valves is being provided: 9000tfx23a/sn# (b)(4)/mfg date 05-apr-2013/exp.Date 26-mar-2015/; 90000tfx23a/sn# (b)(4)/mfg date 05-apr-2013/exp date 26-mar-2015.Cine images were submitted to edwards for review.The following observations/impressions were made: moderate aortic valve calcification, moderate aortic root calcification, no porcelain aorta, and no mitral annular calcification (mac).Coaxial alignment of the sheath was poor.The image intensifier angle was poor.The valve was positioned and deployed in a 70:30 position.Post deployment angiogram demonstrates aortic regurgitation.The second valve was positioned slightly ventricular to the first valve.Impressions: significant aortic regurgitation may be attributable to too-aortic positioning with non functioning leaflet, severe canting, valve undersizing, or eccentric calcification.In the absence of echo, this differential cannot be significantly narrowed.Tee would be helpful to further evaluate the precise cause of the event.Investigation is ongoing.

• Brand Name: EDWARDS 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: 3626296
• MDR Text Key: 4339187
• Report Number: 2015691-2014-00334
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2014

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 Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2014; 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46