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

Model Number 9000TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 04/08/2014

Event Type  Injury  

Event Description

In a transaortic tavr procedure, post deployment the sapien valve position was too ventricular (20:80 aortic/ventricular) with severe central and paravalvular leak and a 2nd valve was implanted.Just prior to deployment it was noticed that the sapien valve was positioned 70:30 a/v.The physician inflating the balloon asked that the surgeon push forward on the valve to get it 50:50 within the annulus but the valve was pushed too ventricular ending its full deployment at 20:80 a/v.This caused severe ai both central and paravalvular.Only two leaflets on the sapien valve were functioning, possibly due to native leaflet overhang.The patient's pressure dropped to below 30mmhg and the team started chest compressions.A 2nd valve was prepped and deployed 50:50 in relation to the 1st sapien valve.The valve was post dilated.All three leaflets were working, but the pressure was still low due to declining lv function.It was decided to put an impella device through the ascendra 3 sheath to assist lv function.A balloon pump was placed in the right femoral artery to assist her recovery from the rapid ventricular pacing runs.At the end of the procedure there was no central leak and trace pvl by echo and angio.The patient left the or in stable condition, but on the balloon pump and vent.Per the latest report, 2 days after the procedure the patient was recovering.

Manufacturer Narrative

Per the instructions for use (ifu), ventricular malposition with central regurgitation and paravalvular leak are a known potential complication associated with the 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, minimally calcified aortic leaflets, and loss of pacing capture.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 a technical summary was written by edwards lifesciences 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, per report the sapien valve malposition with subsequent central and paravalvular leak appears to be related to procedural factors (e.G.Movement of the delivery system by the operator during deployment).It was felt that the suboptimal coaptation of the valve leaflets was possibly due to native leaflet overhang.There was no allegation or indication 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; therefore no further actions are required.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.

• 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: 3793051
• MDR Text Key: 4388210
• Report Number: 2015691-2014-01032
• 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: 04/08/2014

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: 02/04/2016
• Device Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/06/2014
• Date Device Manufactured: 02/17/2014
• 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: 90 YR
• Patient Weight: 66