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

Model Number 9600TFX26

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Obstruction/Occlusion (2422)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: event date is unknown.The valve was not returned to edwards lifesciences for evaluation.Information regarding the disposition of the valve was not provided.Per the instructions for use (ifu), decrease of cardiac output is a potential adverse event associated with the use of transcatheter heart valves.Decreased cardiac output is the reduction in outflow of blood from the ventricles of the heart and often accompanied by increase of pressure gradient.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 gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular aortic stenosis.There are multiple potential causes for decrease in cardiac output, including hcm, valvular heart disease, myocardial infarction, congenital heart disease, cardiac arrhythmias, pulmonary disease, hypertension, fluid overload, drug effects, electrolyte imbalance and decreased fluid volume.Geriatric patients are at a high risk of suffering from decrease cardiac output due to the reduced compliance of ventricles which results from aging.Furthermore, obstruction of the lvot can be caused by patient factors (hcm, septal bulge, mitral regurgitation) or procedural factors (reduction of afterload following valve deployment).Depending on the degree of obstruction, cardiac output, pressure gradient and hemodynamic stability may be affected.In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require additional intervention.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.Obstruction of the left ventricular outflow tract can be caused by patient factors (anterior mitral leaflet protruding into the lvot, septal bulge) or procedural factors (positioning of the valve frame within the annulus).Depending on the degree of obstruction, cardiac output and hemodynamic stability may be affected.Inaccurate deployment is generally a result of use error or a combination or patient and procedural factors.In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require explanation of the thv with surgical correction.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the lvot obstruction is unknown, however per report, may have been due to procedural factors (overexpansion of the first thv resulting in significant ventricular flaring of the first thv; and visibly deformed the bulky struts of the surgical valve.That alone may have reduced the lvot and is not taken into consideration during the neolvot prediction.Ventricular flaring of the first thv also results in a cone-like configuration of the thv.This funnel creates a situation where a second valve is more likely to dive.As a result, the tmvr-intmvr may have ended up more ventricular than desired, i.E.Lower than assumed during the calculation of the neo-lvot on ccta.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 at this time.This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2019-03680.

Event Description

As reported through journal article titled, "surgical bailout for left ventricular outflow tract obstruction following a complicated mitral valve-in-valve procedure", post valve in valve (23mm sapien 3 in 25mm surgical valve) tmvr, tee showed a small residual pvl jet.A 25mm non-compliant balloon was used to dilate the valve (approx.11.5% oversize of the inner diameter).Tee post dilatation showed improvement in the pvl and severe mitral regurgitation, consistent with disruption of the thv leaflets.Given the previous dilation with a 25 mm non-compliant balloon, a 26 mm sapien 3 thv was implanted as a thv-in-thv, at the same depth as the previous thv.The tee following the placement of the second thv now showed a significant gradient across the neo-lvot with a jet velocity n 3 m/s.Despite this, the patient was doing well and was managed medically at first.Given the etiology of obstruction and associated mortality, the patient was scheduled for elective redo-mitral valve replacement.The previous surgical valve and two thvs within it were all explanted.A 27 mm non-edwards valve was implanted, and the patient recovered from the surgery without further complications.The patient was discharged home on postoperative day 7 and continues to do well during follow up.Note: this description pertains to the second thv implanted valve.

Manufacturer Narrative

Bibliography: m.C.Wyler von ballmoos, c.M.Barker, p.R.Kothapalli, et al., surgical bailout for left ventricular outflow tract obstruction following a complicated mitral valve., cardiovascular revascularization medicine, https://doi.Org/10.1016/j.Carrev.2019.07.027.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 9157857
• MDR Text Key: 163595919
• Report Number: 2015691-2019-03692
• Device Sequence Number: 1
• Product Code: NPU
• 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: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• 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: 64 YR
• Patient Sex: Female