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

Model Number	9300TFX29
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Hemolysis (1886); Insufficient Information (4580)
Date of Event	01/26/2023
Type of Reportable Event	Death
Event or Problem Description
As reported by the field clinical specialist, approximately 7 years, 9 months post-implant of a 29 mm sapien xt valve in the aortic position, valve required intervention due to stenosis.The patient expired prior to surgical intervention.The cause of death remains unknown as the patient expired outside of a medical facility.
Additional Manufacturer Narrative
Investigation is ongoing.Device was not returned.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.Edwards has reported the death to be conservative as we do not know the cause of death, even after medical records were received.Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Imagery was provided by the site and revealed calcification that appeared on the leaflets.The reported event does not allege a device malfunction that could be related to an edwards manufacturing deficiency.Therefore, a lot history review is not required.The novaflex+ delivery system with sapien xt ifu was reviewed.Stenosis is a known potential adverse event.Noted under potential adverse events, 'valve stenosis'.No ifu/training deficiencies were identified.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 the failure mode is not required at this time.The complaint was confirmed from medical record provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals also revealed no deficiencies.During the manufacturing process, all sapien xt 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.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 listed in the instructions for use for the thv procedure and are known potential risks associated with the device.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd refers to changes intrinsic to the valve and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.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.Per medical record, patient had chronic kidney diseases or esrd (end stage renal disease) in dialysis.Chronic kidney disease is a known factor that may increase the risk of valve calcification leading to early valve degeneration/stenosis.As such, available information suggests that patient factors (chronic kidney disease) may have contributed to the complaint event.Since no device problem was identified affecting distributed product, no pra or capas are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.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 XT TRANSCATHETER HEART VALVE
• Common Device Name: 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: 16378370
• Report Number: 2015691-2023-10812
• Device Sequence Number: 17570052
• Product Code: NPT
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)161006
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2016
• Device Model Number: 9300TFX29
• Device Catalogue Number: 9300TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 03/24/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/17/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Female