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

Model Number 9600TFX23A

Device Problems Incomplete Coaptation (2507); Thickening of Material (4056)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.H3 other text : not returned.

Event Description

As reported by the edwards lifesciences affiliate regarding a 23mm sapien 3 valve in the aortic position, approximately 4 years post valve implantation, the valve was explanted and replaced with a surgical valve due to halt and leaflet motion restriction.

Manufacturer Narrative

The device remains implanted in the patient.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The reported events were confirmed based on the medical record.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have hypoattenuated leaflet thickening (halt) may be caused by several patient-related factors including early valve deterioration (svd) (e.G.Stenosis calcification), non structural dysfunction (e.G.Pannus), or thrombosis.In this case, it was reported that there was possible clot under the leaflet and that the patient had diabetes and hypercholesterolemia.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in leaflet thickening.Diabetes is a known factor that may increase the risk of valve calcification leading to early valve degeneration stenosis.Hypercholesterolemia has been found to be associated with aortic valve stenosis and to resemble the inflammatory process of atherosclerosis in many studies.As such, available information suggests patient factors (thrombosis, diabetes, hypercholesterolemia) may have contributed to the reported event.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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
• 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: 18717778
• MDR Text Key: 335522984
• Report Number: 2015691-2024-01075
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female