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

Model Number 9600TFX20A

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, approximately 18 months post valve in valve (20mm sapien 3 in surgical valve) tavr procedure, the patient developed shortness of breath and an increased gradient.At the time of the sapien 3 implant, the physician decided not to fracture the surgical valve.However, due to the increased gradient post implant, the 20mm sapien 3 valve was post dilated with a 24mm true balloon.This fractured the surgical valve ring but created moderate-severe central leak.The decision was made to deploy a 23mm sapien ultra valve.The post op echo showed pvl and central ai reduced to none.The patient left the room in stable condition.

Manufacturer Narrative

Section h10: additional information provided clarified that post implant of the original 20mm sapien 3 valve, no procedural complications or ew device malfunctions were reported.Bav was performed with a 23mm balloon prior to valve deployment, and the 20mm sapien 3 valve was noted to have some residual waist, no ai by tee.One month post the tavr procedure, the 20mm sapien 3 valve had "relatively high gradients" due to the small size of the valve used as well as patient prosthetic mismatch.The patient was feeling well and had no complaints.Echo showed, an aortic mean gradient of 30mmhg, no ai or pvl.Approximately 13 months later tte showed the aortic valve with a peak gradient of 70mmhg, a mean gradient of 38mmhg, no ai or pvl and a mitral prosthesis with mild mr.Approximately four months later a 24 mm true balloon was used to bav in order to fracture the surgical valve and expand the 20mm existing sapien 3 valve.This created wide open ai, therefore deployment of a 23mm sapien 3 valve was successfully done.There were no procedure complications and the valve had a post deployment gradient of 15mmhg, no ai.However, pod#1 echo showed the 23mm sapien 3 valve was not well seated with probable moderate/severe prosthetic aortic valve stenosis and a mean peak gradient of a 32mmhg.As the patient was symptomatic with sob and doe, on pod18 the patient¿s 20mm sapien 3 valve was explanted and replaced with a 25mm magna ease surgical prosthesis.The patient was discharged to rehab on pod7.

Manufacturer Narrative

Additional information: b7, d4, d6, d7, h4, h6 and h10.Section h10: udi reference number: (b)(4).Additional information provided by the hospital medical records indicated that post valve-in-valve (20mm sapien 3 valve in the 23mm mosaic ultra valve) tavr procedure, the patient developed recurrent chf with a mean gradient in the high 30¿s.Approximately eighteen months after the tavr procedure, the patient underwent a valvuloplasty with an attempt to fracture the valve with placement of a 23mm sapien 3 valve; however, the valve gradient got worse (with mean gradient over 40 mmhg).Tte done on the following day reported that there was no aortic insufficiency and an aortic mean gradient of 32 mmhg.¿the prosthetic valve is not well-seated¿ with probable moderate-severe prosthetic aortic valve stenosis.The patient continued to present symptoms of chf.After discussing options, it was elected to discharge the patient and re-admit 2 weeks (18 days) later to undergo redo aortic valve replacement (avr) due to prosthetic valve mismatch with severe aortic valve stenosis.Per the operative report, the ¿patient has multiple layers of prosthetic valves in the aortic position, which caused relatively small opening of the transcatheter valve¿.The sapien 3 valves and the previous mosaic ultra valve were removed and replaced with a 25mm magna ease valve.The patient tolerated the avr procedure well and was discharged home 7 days after the avr procedure.A device history record review (dhr) was performed and did not reveal any manufacturing issues that could have contributed to the event.It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradient may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and patient becomes symptomatic, it may require intervention.High residual mean gradient for a ¿tav-in-sav¿ is listed in the valve in valve instruction for use (ifu) as a potential risk associated with the use of the thv configuration than that observed following implantation of the thv inside a native aortic annulus using the same size device.Patients with elevated mean gradient post procedure should be carefully followed.It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate thv can be implanted and a prosthesis-patient mismatch be avoided.Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the internal orifice as possible.Patient¿prosthesis mismatch (ppm) is present when the effective orifice area (eoa) of the inserted prosthetic valve is too small relative to body surface area.Ppm is defined as an eoa indexed for body surface area < 0.8-0.9 cm2/m2 in the aortic position and < 1.2-1.3 cm2/m2 in the mitral position.This is a frequent problem in patients undergoing aortic or mitral valve replacement (20¿70% prevalence), and its main hemodynamic consequence is to generate high transvalvular gradients through normally functioning prosthetic valves.Ppm is associated with worse hemodynamics, less regression of left ventricular hypertrophy, more cardiac events, and higher mortality rates after aortic valve replacement.Ppm is also a frequent problem after mitral valve replacement, where it is associated with less regression of pulmonary hypertension and higher mortality.In this case, per report, the increased gradient eighteen months post valve implant was attributed to patient-prosthesis mismatch.The central leak was caused by the post dilatation, at the time the surgical valve was fractured.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.

Manufacturer Narrative

Related to mfgr.Report number: 2015691-2020-11698.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9891758
• MDR Text Key: 190950701
• Report Number: 2015691-2020-11210
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2020

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: 02/29/2020
• Device Model Number: 9600TFX20A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 03/30/2020; 04/26/2020; 04/23/2020
• Supplement Dates FDA Received: 04/24/2020; 04/26/2020; 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR