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

Model Number	9300TFX23A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by compassion clinical study, post tpvr procedure with a 23mm sapien 3 xt valve, the patient presented to the hospital with chest pain, and echo report revealed right heart dysfunction along with moderate stenosis and insufficiency.The valve was explanted.Per report, moderate residual regurgitation was observed following pulmonary valve intervention.
Additional Manufacturer Narrative
Investigation is still ongoing.
Additional Manufacturer Narrative
The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Per the valve academic research consortium (varc), valve stenosis can result from several factors, including pannus, calcification, support structure deformation (out of round configuration), trauma (cardia pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term 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 severity it could be an indication for valve replacement or medical intervention.Due to insufficient information, a definitive root cause is unable to be determined.Per the instructions for use (ifu), valve regurgitation is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.In this case, the patient had stenosis which can in turn interfere with normal coaptation functionality of the device by restricting the leaflet motion, and thus, resulting in central regurgitation.In this case, the patient had stenosis, which could have suboptimal leaflets coaptation leading to valve regurgitation.As such, available information suggests that patient factors (stenosis) may have contributed to the complaint event.In this case, the stenosis and regurgitation were confirmed by records received.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 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: 18195028
• Report Number: 2015691-2023-17688
• Device Sequence Number: 20443001
• Product Code: NPT
• UDI-Device Identifier: 00690103192070
• UDI-Public: (01)00690103192070(17)210308
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 02/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 9300TFX23A
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 02/03/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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 Age: 17 YR
• Patient Sex: Male