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

Model Number 9600TFX29

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Hemolysis (1886)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for patients with symptomatic heart disease due to 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 high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).  the sapien 3 valve is not indicated for placement in the native mitral position.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In addition the ifu offer the following precaution:  safety and effectiveness have not been established for patients with severe mitral annular calcification (mac), sever (>3+) mitral insufficiency, or gorlin syndrome.In this case, there was no allegation or indication a device malfunction contributed to this adverse event. investigation results indicate that the author believes the successful placement of a transcatheter valve in the native mitral position in the presence of mac is more challenging due to higher systolic pressures exerted on the closed mitral valve compared with lower diastolic pressure on an aortic prosthesis.In addition, the author states the addition of a felt strip around the outside of the valve (has been) an important advance in the reduction of pvl in the native mitral position (open atrial approach).  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 through article ¿open atrial transcatheter mitral valve replacement in patients with mitral annular calcification¿, one patient with mild paravalvular leak (pvl) post-tmvr with the sapien 3 valve, developed hemolysis six months post-tmvr (trans-atrial approach) that was successfully treated with percutaneous closure using a vascular plug.

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: 7971410
• MDR Text Key: 123944807
• Report Number: 2015691-2018-04208
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2017
• Device Model Number: 9600TFX29
• 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): Required Intervention