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

Model Number 9600TFX23J

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

Patient Problems Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

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.Although a root cause for the event was not reported, investigation results suggest in addition to procedural factors (no post dilation of the deployed valve), patient factors (valvular calcification) may have contributed to the moderate to severe pvl post tavr and subsequent re-dilation of the valve on pod2.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 by our affiliate in (b)(6), pre-operative aortic regurgitation (ar) was noted to be mild to moderate.During a transfemoral tavr procedure, a 23mm sapien 3 valve was deployed with nominal volume in the aortic annulus in a final 85:15 aortic/ventricular position.After valve deployment, diastolic blood pressure (dbp) was 30¿s mmhg.It was determined that the degree of paravalvular leak (pvl) was less than or equal to pre-operative ar.The procedure was finished.After returning to the ccu, echo examination showed moderate to severe pvl.On postoperative day (pod) 2, the sapien 3 valve was re-dilated using a 23mm edwards balloon catheter with 1.5ml additional volume.The pvl was decreased to mild.The dbp increased from 35mmhg to 45mmhg.The procedure was completed.On pod5, the following course was favorable, and rehabilitation was started.Per the physician, deployment of the valve with 1.0ml additional volume was possible; however, it was difficult to decide whether to perform the post-dilation after valve deployment.The annulus area measured approximately 400.0 mm2.Mild aortic valve calcification was reported.The valve remains implanted in the patient and will not be returned for evaluation.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 10379092
• MDR Text Key: 202518200
• Report Number: 2015691-2020-12961
• 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
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 9600TFX23J
• 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: 83 YR