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

Model Number 9755RSL26A

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a tmvr procedure with a 26mm sapien 3 ultra valve, the patient came back with significant paravalvular leak (pvl) with dyspnea and fatigue.The patient was treated with post dilation using 26 mm commander delivery system.The patient was stable after post dilation.There were no allegations of an edwards device malfunction.

Manufacturer Narrative

Correction to h6 based on additional information.The complaint for paravalvular leak was unable to be confirmed due to unavailability of medical record/procedural imagery.A review of the device history record (dhr) review revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of instructions for use (ifu)/training materials revealed no deficiencies.It should be noted that the thv was implanted in native mitral position with mitral annular calcification (mac) for this case.The sapien 3 ultra resilia (s3ur) with the commander delivery system (ds) was indicated for native aortic valve, surgical and transcatheter bioprosthesis aortic valve, surgical bioprosthesis mitral valve and native mitral valve with an annular plasty ring replacement only.So, it was considered an off-label operation.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement procedure.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 pvl, as reported in this case, is not well understood but may be related to cardiac remodeling.As reported, 'during a tmvr procedure with a 26mm sapien 3 ultra valve, the patient came back with significant paravalvular leak (pvl) with dyspnea and fatigue.The patient was treated with post dilation using 26 mm commander delivery system.The patient was stable after post dilation'.In this case, post-dilation was performed, which indicated deployed valve under expanded.In additional, implanting valve in native mitral annulus could be challenging due to the bicuspid leaflets with non-circular shape of native mitral annulus, which could potentially prevent the pvl skirt to seal against the target site (native annulus), and also restricted valve expansion resulting in paravalvular leak.As such, available information suggests that procedural factors (under expanded valve, off label operation) may have contributed to the complaint event.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 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15889702
• MDR Text Key: 304589606
• Report Number: 2015691-2022-09567
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)250803(11)220804219831088
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9755RSL26A
• Device Catalogue Number: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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