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

Model Number 9600TFX29A

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); No Code Available (3191)

Event Date 01/15/2020

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.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter mitral 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.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.The patient screening manual instructs the operator on proper mitral valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the pvl is unknown but may be due the factors mentioned above.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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, during a transapical tmvr procedure, after successful laceration of the anterior mitral valve leaflet to prevent outflow track obstruction procedure, (lampoon) and deployment of the 29 sapien 3 valve, echo showed the patient had moderate-severe perivalvular leak (pvl).A second 29mm sapien 3 valve was deployed in order to treat the pvl, as it was believed the source of the leak was through the open struts of the first valve implant.This made things markedly better, however the leak was still considered moderate.A vascular plug was then deployed, outside of both valves, resolving the pvl.The patient required cpb support during the procedure and left the operating room on ecmo.It is perceived that the pvl was caused by patient factors.

Manufacturer Narrative

B5, d2.

Event Description

As reported, during a transapical tmvr procedure, after successful laceration of the anterior mitral valve leaflet to prevent outflow track obstruction procedure, (lampoon) and deployment of the 29 sapien 3 valve in the mitral position, echo showed the patient had moderate-severe perivalvular leak (pvl).A second 29mm sapien 3 valve was deployed in order to treat the pvl, as it was believed the source of the leak was through the open struts of the first valve implant.This made things markedly better, however the leak was still considered moderate.A vascular plug was then deployed, outside of both valves, resolving the pvl.The patient required cpb support during the procedure and left the operating room on ecmo.It is perceived that the pvl was caused by patient factors.

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: 9665995
• MDR Text Key: 177986018
• Report Number: 2015691-2020-10375
• 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,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• 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: 73 YR