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

Model Number 9000TFX23

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

Patient Problem Aortic Regurgitation (1716)

Event Date 04/04/2014

Event Type  Injury  

Event Description

During a transapical tavr procedure the 23mm sapien valve was deployed canted and in a too ventricular position causing central aortic insufficiency for which a second valve was implanted.Per report, following valve deployment, tee showed mild paravalvular leak and moderate central aortic insufficiency.It is believed that significant calcification by non-coronary cusp pushed valve ventricular and that there was possibly some leaflet overhang.It appeared on echo that one of the leaflets was not moving.The patient then became hemodynamically unstable, was placed on bypass and inotropes were given.While the patient was on bypass, she developed ventricular fibrillation three times and was defibrillated successfully each time.The patient was given amiodarone after the second time she went into ventricular fibrillation.Once the patient was hemodynamically stable and was in a paced ventricular rhythm, the team deployed a second 23mm sapien valve about 2-3mm beyond the outflow of the 1st sapien valve.Tee showed mild paravalvular leak and trace central aortic insufficiency.The patient was weaned off bypass and the apex was successfully closed.The patient was transferred to the unit for post-op management and in stable condition.The native valve/leaflet calcification was severe; mitral annular calcification was mild.Coaxial alignment of the delivery system and the valve was fair; the image intensifier angle was adequate; there was no loss of pacing capture during valve deployment and ventilation was held.The sinotubular junction (stj) diameter was 26mm.The patient¿s ejection fraction was 40%.

Manufacturer Narrative

Per the instructions for use (ifu), ventricular malposition with central regurgitation is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction, and minimally calcified aortic leaflets.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 ventricular malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment edwards created a technical summary to document the results of testing performed by edwards to study low sapien thv deployment with resulting aortic regurgitation.This clinical event was investigated by examining clinical imaging video which led to an identification of native leaflet overhang over the thv implant.This condition was simulated on the bench to examine the variables that would prevent one or more leaflets from closing during diastole.Based on the analysis of the video and subsequent in vitro testing, it is evident that low placement can lead to native leaflet overhang.However, the overhanging leaflet must be fairly mobile (not heavily calcified) and the position of the overhang relative to the leaflet and commissures may also be important in causing regurgitation.This may explain why low placement can occur without regurgitation.In this case, patient and procedural factors appear to have caused the valve malposition [significant calcification by the non-coronary cusp which pushed the valve ventricular during deployment, the canted and ventricular position of the valve allowed for native leaflet overhang/leaflet motion restriction causing aortic insufficiency; less than optimal coaxial alignment of the delivery system and the valve].There is no evidence this event as due to sapien valve or the ascendra 3 delivery system.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 (b)(4) basis, and any excursions above the control limits are assessed and documented as part of this (b)(4) 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: 3778329
• MDR Text Key: 4374841
• Report Number: 2015691-2014-00983
• 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
• Report Date: 04/04/2014

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: 03/20/2015
• Device Model Number: 9000TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/29/2014
• Date Device Manufactured: 04/05/2013
• 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
• Treatment: ASCENDRA 3 DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR