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

Model Number	9300TFX29A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Syncope/Fainting (4411)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.Device remains implanted.
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 7 years 10 months post transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29mm sapien xt valve, the patient underwent a valve in valve procedure with a 29mm sapien 3 valve due stenosis and regurgitation.The 29mm sapien 3 valve was implanted successfully without any issues and the patient is doing fine.Additional information received via medical records revealed approximately 7 years 8 months post tavr procedure, there was moderate aortic insufficiency observed along with a mean gradient of 39mmhg which is consistent with bioprosthetic valve stenosis.The aortic valve area (ava) (vti) was 0.96cm2.Approximately 7 years 9 months post tavr procedure, the patient reported dizziness and progressive dyspnea on exertion over the past year.The patient had been admitted previously for a fall related to near syncope.The patient also has lower extremity edema.Further work up revealed a degenerated tavr valve and there was evidence of degenerated tavr leaflets.The mechanism of failure was noted to be both aortic stenosis and aortic regurgitation.The aortic regurgitation appeared to be central.
Additional Manufacturer Narrative
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 patient factors caused or contributed to this event.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: 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: 16480889
• Report Number: 2015691-2023-11241
• Device Sequence Number: 3126353
• Product Code: NPT
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)170104
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 01/04/2017
• Device Model Number: 9300TFX29A
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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: Required Intervention
• Patient Sex: Male