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

Model Number 9600TFX29

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problems Tricuspid Regurgitation (2112); Regurgitation (2259)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), a tricuspid valve in ring procedure was planned due to right ventricle disease, resulting in worsening tricuspid regurgitation.A 29mm sapien 3 valve was deployed in the pre-existing tricuspid ring.The sapien 3 valve was successfully implanted in the rigid ring.It was noted that the sapien 3 valve did not completely fill the space inside the ring, resulting in paravalvular leak (pvl).No actions were taken at the time of the procedure.After monitoring the patient, it was determined that a plug will probably be needed to resolve the pvl.At the time of the report, the patient was in stable condition.

Manufacturer Narrative

Corrected information: section g4 date received by manufacturer.An error was made in section g4 information in the initial submission.The g4 aware date has been changed to the correct aware date of (b)(6)2020.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The sapien 3 valve remains implanted in the patient.No further information regarding the planned plug implant was provided.A supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) 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 aortic 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.Despite multiple investigational attempts, it was not possible to obtain additional details regarding the reported event.Investigation results suggest procedural factors (valve deployment in rigid tricuspid ring) likely contributed to the post deployment pvl requiring intervention.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10283428
• MDR Text Key: 200055039
• Report Number: 2015691-2020-12531
• Device Sequence Number: 1
• Product Code: NPT
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: 9600TFX29
• 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