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

Model Number 9600TFX23

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Mitral Insufficiency (1963); Mitral Regurgitation (1964)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Valve migration and regurgitation are potential risks associated with the use of the valve. according to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the landing zone.Less-than-severe and non-uniformly distributed calcification, incorrect valve sizing, and incomplete frame expansion, and can contribute to valve migration.Malposition is another risk factor for migration and regurgitation.If the valve is deployed too atrial, it may not cover the native mitral valve.As a result, the native mitral leaflet deflected flow, creating a venturi effect where a reduction in blood pressure resulting in mitral regurgitation.The edwards sapien 3 transcatheter heart valve is 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., society of thoracic surgeons operative risk score =8% or at a =15% risk of mortality at 30 days).  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. the device remains implanted in the patient.In this case, the cause of the valve migration and subsequent mitral insufficiency noticed one month post deployment of the s3 valve in the native mitral annulus cannot be determined.However, there was no allegation or indication of a device malfunction.It is possible that some of the risk factors mentioned above caused or contributed to the 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.

Event Description

As reported, approximately 1 month post transcatheter mitral valve replacement (tmvr) with a 29mm s3 valve in the native mitral position via transseptal approach, the patient developed mitral insufficiency and a 2nd valve was implanted.  per report, the physician believed the 1st valve migrated and left the patient with mitral insufficiency.

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: 8638674
• MDR Text Key: 146041268
• Report Number: 2015691-2019-01850
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2020
• Device Model Number: 9600TFX23
• 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
• Patient Age: 67 YR