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

Model Number 9600TFX26

Device Problem Perivalvular Leak (1457)

Patient Problems Death (1802); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

The edwards sapien 3 transcatheter heart valve and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve, who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.The patient screening manual instructs the operator on proper aortic valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the pvl is unknown as the presentation does not go into detail.However, investigation results (suggest/indicate) the pvl may be related to patient factors (pre-existing surgical valve) and/or procedural factors (device manipulation).The cause of the patient¿s death is also unknown but may be due to the patient comorbidities (ischemic stroke, pulmonary emphysema with copd ).There was no indication that a dysfunction of the implanted sapien 3 valve or an injury from an edwards device caused or contributed to the patient death post procedure.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.

Event Description

As reported by our affiliate in (b)(6) and through a pcr congress presentation, "transcatheter mitral paravalvular leak closure after transcatheter mitral valve-in-valve replacement", during a trans-septal mitral valve-in-valve (viv) procedure, a 26mm sapien 3 valve was deployed in a pre-existing mitral biologic prosthesis due to severe stenosis (mean gradient of 12mmhg).Post valve deployment, moderate-severe mitral paravalvular regurgitation on the anterio-septal side but without significant mitral stenosis (mean gradient of 3mmhg) and without left ventricular outflow tract obstruction was observed.¿bad clinical evolution with heart failure refractory to medical treatment¿ was reported.During an attempt to reduce the mitral paravalvular leak (pvl), an implantation attempt of an amplatzer vascular plug on the anterior-septal side was performed without success.However, the implantation attempt of an amplatzer vascular plug on the anterior-septal side was successful.An acceptable echocardiographic result with mild-moderate mitral paravalvular regurgitation on the anterior-septal side, without significant mitral stenosis (mean gradient of 6mmhg) and without left ventricular outflow tract obstruction was reported.Post procedure, ¿bad evolution with multiple complications¿ occurred.And finally, exitus letalis (the patient expired).

Manufacturer Narrative

Reference for article: armario, x.Transcatheter mitral paravalvular leak closure after transcatheter mitral valve-in-valve replacement (2019).Pcr congress (17, 18 and 19 november), london.Https://www.Pcronline.Com/courses/pcr-london-valves.

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; 1 edwards way; irvine CA 92614
• MDR Report Key: 9553010
• MDR Text Key: 189437854
• Report Number: 2015691-2020-10031
• Device Sequence Number: 1
• Product Code: NPU
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 77 YR