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

Model Number 9750TFX26A

Device Problem Difficult to Open or Close (2921)

Patient Problem Dyspnea (1816)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device remains implanted.

Event Description

As reported from field clinical specialist, approximately 2 years and 6 months post tavr with a 26mm sapien 3 ultra valve in the aortic position, the valve was failing due to stenosis.Per proctor review of imaging although the patient was treated for possible thrombus, halt is confirmed.The patient is being treated with medication.Per clinical review of medical records received halt was found on ct images.The patient is now being evaluated for a valve replacement.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.The complaints for post implantation leaflet thickening was confirmed based on the provided imagery and medical record.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance contributed to the reported event.A review of the ifu and training manuals revealed no deficiencies.The device was not returned for evaluation.As device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported ''approximately 2 years and 6 months post tavr with a 26mm sapien 3 ultra valve in the aortic position, the valve was failing due to stenosis.Per proctor review of imaging although the patient was treated for possible thrombus, halt is confirmed.The patient is being treated with medication''.Hypoattenuated leaflet thickening (halt) may be caused by several patient-related factors including early valve deterioration (svd) (e.G., stenosis), non-structural dysfunction (e.G., pannus), or thrombosis (formation of blood clots on the valve).In this case, thrombosis is suspected, and the patient was being treated with medication.Valve thrombosis refers to the formation of significant blood clots on the valve.These clots have the potential to significantly impact the functionality of the valve, resulting in leaflet thickening.As such, available information suggests that patient factors (thrombosis) 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 ULTRA 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: 18975476
• MDR Text Key: 338549509
• Report Number: 2015691-2024-02294
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230422
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: Male