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

Model Number 9600TFX23

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2023

Event Type  Injury  

Event Description

As reported, during valve deployment, the first 23mm sapien 3 valve landed in a very low position (approx.10:90) in the annulus probably due to loss of capture during rapid pacing or due to a calcified sinotubular junction.Paravalvular leak was noted so a second valve of same size was implanted to capture it.

Manufacturer Narrative

Investigation is ongoing.Device remains implanted.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-10828.The device was not returned to edwards lifesciences for evaluation, as the device remains implanted.Therefore, no visual inspection, functional testing or dimensional testing could be performed.No imagery was provided for review.The commander delivery system with s3 ifu and procedural training manual were reviewed.Loss of pacing capture can occur during rapid pacing.No ifu/training deficiencies were identified.The malposition and paravalvular leak were unable to be confirmed as no imagery/medical record were provided for evaluation.There was no allegation or indication a device malfunction contributed to this adverse event.A review of ifu/training materials revealed no deficiencies.As reported, ''during valve deployment, the first 23mm sapien 3 valve landed in a very low position (approx.10:90) in the annulus probably due to loss of capture during rapid pacing or due to a calcified stj.Pvl was noted so a second valve of same size was implanted to capture the first valve.'' during procedure, rapid pacing is performed to provide transient reduced cardiac output to facilitate balloon stability during valve deployment.Per the training manual, loss of capture during rapid pacing can cause sudden delivery system movement during deployment.In this case, the loss of pacing capture likely disrupted the balloon stability during post deployment, which could have contributed to the malpositioned thv.Additionally, the presence of calcified stj could have an impact on the thv deployment characteristics (e.G.Anatomical constrains can lead to poor coaxial alignment of ds/thv, which can in turn cause the valve to shift downward during balloon inflation) therefore, loss of pacing capture in conjunction with the calcified stj likely caused the thv to land too ventricular upon deployment.As such, available information suggests that procedural (loss of pacing capture) and patient factors (calcified stj) may have contributed to the complaint event.Due to the thv malposition, wherein the valve was deployed too low (approx.10:90), the pvl skirt was most likely unable to properly seal against target site, resulting in paravalvular leak (pvl).As such, available information suggests that procedural factors (thv malposition) may have contributed to the complaint event.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.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.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16382763
• MDR Text Key: 309634689
• Report Number: 2015691-2023-10829
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention