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

Model Number 9750TFX26A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by a field clinical specialist, post tavr (unknown date) with a 26mm sapien 3 ultra valve, the valve failed due to regurgitation/pvl.A 26mm sapien 3 ultra resilia valve was implanted in a valve in valve procedure.

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information received from implant registry.The investigation is ongoing.

Event Description

Per clinical review of medical records, a tee approximately 7 years post tavr showed moderate/severe stenosis and central ar as well as "symptomatic severe degeneration of the tavr valve".

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information and correction from medical records and from a product investigation.The following sections of this report have been updated: b.4, b.5, b.7, g.3, g.6, h.2 and h.6.The following sections of this report have been corrected: h.6 device code (from 1457 and 1250 to 1153).Per the instructions for use (ifu), structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis), and device degeneration are known potential risks associated with bioprosthetic heart valves.The ifu cautions that accelerated deterioration of the valve may occur in patients with an altered calcium metabolism.Long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.Depending on the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.The mechanisms for bioprosthetic heart valve tissue calcification are not yet fully understood.Many factors can contribute to the onset and propagation of calcification including patient-related (e.G., patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.During the manufacturing process, all sapien thv valves are 100% visually inspected for defects and 100% functionally 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.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate a definitive root cause could not be determined due to limited information provided.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 18959815
• MDR Text Key: 338367544
• Report Number: 2015691-2024-02217
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)171013
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2017
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: Not provided; 04/23/2024
• Supplement Dates FDA Received: 04/19/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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