MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Regurgitation (1716); Occlusion (1984)

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation of these events is ongoing.

Event Description

During a transfemoral tavr procedure, after the deployment of a 29mm sapien 3 valve had moderate-severe central leak and a second valve was implanted.In addition, 2 coronary stents were implanted.Prior to the procedure, the team was aware that the patient¿s left main artery (lm) origin was low.The lm height ¿ 8mm the right coronary artery (rca) height was 15mm.The team planned to look for coronary occlusion during bav to determine if lm protection was necessary.After using the 25x4 bav balloon it was decided, as a preventative measure, to wire the left anterior descending (lad) coronary artery with a coronary stent mounted on the wire.The 29mm ds/s3 valve was placed across the native annulus.At that time, there was a malfunction of the contrast injector which caused a prolonged amount of time with the devices across de annulus, so the ds/s3 was pulled back into the ascending aorta.The devices were advanced again and they deployed the valve with 1cc less than the nominal volume.Shortly after the patient had significant hypotension and the lv stop moving.Cpr was initiated and a bolus of epinephrine was given.Contrast injection showed both the lm and the rca were opened.However, it was decided to pull back the coronary stent that was sitting in the wire on the lad and deploy it on the lm trunk.There was no coronary occlusion, but they wanted to prevent a possible injury caused by pulling out the wire during an emergent situation.The patient still had persistent hypotension with periods of v-fib and v-tach with repeated shock therapy.Due to the low blood pressure, it was not possible to evaluate the post deployment position and function of the 29mm s3 valve.Once the patient stabilized it was noticed that the ncc leaflet of the 29mm s3 valve was not moving and the valve had moderate-severe central leak.They tried to get it to work by moving the guidewire, but were not successful.They decided to deploy a 2nd valve.A 26mm s3 valve was implanted with nominal volume at a slightly lower position within the 29mm s3 valve.The patient has a small stj and low coronary ostium height, so they felt it was better to go with the smaller valve.While waiting for the 2nd valve, the patient was placed on fem-fem bypass.The 2nd s3 valve was deployed 1-2mm lower than the 1st valve, approximately at a 70:30 aortic/ventricular position.Post deployment there was mild pvl and no central leak.Post deployment of the 2nd valve they checked the coronary arteries again.The rca was open, but it looked like the top part of the s3 valve was on top of the rca ostium and it was decided to balloon the rca and deploy a coronary stent as a preventative measure.The patient was weaned off bypass and transitioned to iabp.

Manufacturer Narrative

Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.Coronary occlusion can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G.Pci).There are multiple patient factors that could contribute to coronary occlusion by the prosthetic valve or native valve leaflets, including a minimal distance between the native annulus and the coronary ostia, bulky calcification, long native leaflets, and obliterated coronary sinuses.Procedural factors such as torn native leaflet during bav, plaque shift, deployment of the bioprosthetic heart valve too aortic and significant valve over sizing could also contribute to this complication.The edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The physician is instructed to evaluate this risk early in the patient screening process in all patients the following factors should be considered: degree of calcification on leaflets, annulus to coronary ostia distance, length of the valve leaflet, width of the valsalva sinuses, movement of the leaflets during bav, patency of coronaries during bav, and expanded height of the intended thv.The training manuals also provide the following tips for detecting risk for left main occlusion: aortogram or tee prior to thv implantation to reveal bulky calcified leaflets; during pre-dilatation, note bulky calcification on valve moving towards ostium on left main; and consider aortogram during valvuloplasty to assess coronary flow.In this case, it was reported that a coronary stent was placed as a preventative measure on the rca, as part of the s3 valve appeared to be on top of the ostium.Even though the s3 valve position cannot be confirmed, it is likely that patient factors (low coronary ostium height) may have also contributed to the event.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, the cause of the reported non-functioning leaflet and moderate-severe central leak post deployment of the s3 valve cannot be determined.Despite multiple requests, imaging of the procedure was not available for edwards lifesciences to review.Without imaging, patient factors (native leaflet calcification), and procedural factors (imaging intensifier angle, valve deployment position, confirmation of leaflet overhang) could not be confirmed/assessed.However, it is possible that the slow recovery of adequate blood flow post valve deployment may 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 3 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: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5724968
• MDR Text Key: 47392278
• Report Number: 2015691-2016-01910
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2017
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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: 67 YR