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

Model Number SAPIEN 3 UNKNOWN

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

The date of the event(s) is unknown.According to the article the date range for this event is from april 2017 to december 2019. for this reason, the first day of the range was used as the occurrence date.  per the instructions for use, paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tmvr) 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.The edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.Deployment of the sapien 3 valve in a native mitral valve, is not indicated per the labeling; therefore, the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.In this case, the cause for the worsening pvl at follow up at 36 days cannot be determined.However, it may be related to patient/procedural factors.No additional patient or procedural factors were provided that could help determine a root cause of the pvl.There is no allegation or indication a device malfunction contributed to this adverse 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.Bibliography: lamelas, joseph, and ahmed alnajar."early outcomes for surgical minimally invasive sapien 3 transcatheter mitral valve replacement." the annals of thoracic surgery (2020).

Event Description

A single-surgeon retrospective all-comers mitral valve replacement (mvr) study was published in the journal article ¿early outcome for surgical minimally invasive sapien 3 transcatheter mitral valve¿.The study was between april 2017 to december 2019 and included 16 patients that underwent mvr-tavr with extensive mac and mitral pathology via a minimally invasive right lateral thoracotomy approach under direct vision with valve anchoring sutures to evaluate the early outcomes shown when using the latest generation of balloon-expandable s3 sapien tavr valve prosthesis.There were no conversions to sternotomy.This complaint is for one patient who developed severe pvl upon follow up at 36 days post procedure requiring transcatheter intervention.

Manufacturer Narrative

This report is 2 of 3 being submitted for this complaint.Reference mfg.Report numbers 2015691-2020-15131 and 2015691-2020-15133.

• Brand Name: EDWARDS SAIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614 ; AF 92614
• MDR Report Key: 11042854
• MDR Text Key: 222642808
• Report Number: 2015691-2020-15132
• 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: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN 3 UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention