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

Model Number 9600TFX29A

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Hemolysis (1886); Mitral Insufficiency (1963); Regurgitation (2259)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Udi reference number: (b)(4).The valve was not returned to edwards lifesciences, as it remains implanted in the patient.A device history record review (dhr) was performed and did not reveal any issues that may have contributed to the complaint event.Per the instructions for use (ifu), valve regurgitation (pvl and central) are potential adverse events 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.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.In this case, the exact cause of the worsening regurgitation is unknown but was likely related to procedure factors (deployment of the valve in a c-shaped ring) or the mechanisms described above.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, eight days post transseptal valve in ring (29mm sapien 3 valve in 34mm ring) tmvr procedure, the patient developed hemolysis and moderate pvl/central regurgitation.A second valve was deployed.The first valve was implanted as intended, in an 80:20 mitral position.Post op echo showed no pvl or central regurgitation.The patient developed hemolysis and did not leave the hospital.Later in the hospitalization, echo revealed moderate regurgitation (pvl and central).On pod8 the patient's valve was post dilated but resulted in no change to the regurgitation grade.The decision was then made to deploy a second valve.A second 29mm sapien 3 valve was deployed in an 80:20 mitral position, as intended.The patient was in stable condition.The post op echo showed none/trace pvl and central regurgitation.It is perceived that the moderate regurgitation was caused by the deployment of a valve in a c-shaped ring.

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; one edwards way; irvine CA 92614
• MDR Report Key: 10388467
• MDR Text Key: 202722103
• Report Number: 2015691-2020-13012
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 9600TFX29A
• 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: 88 YR