MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT; PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9300TFX29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a thv procedure with a 29mm sapien xt valve in pulmonic position.Approximately 7 years 11 months later, the patient presented with a failed valve due to pulmonic regurgitation with no clinically significant gradient.The valve was predilated with a 28mm balloon, yielding a residual diameter of 25.5mm.Next, a 26m sapien 3 valve was delivered via a 26fr non-edwards sheath and inflated to nominal volume inside the pre-existing 29mm sapien xt valve.The patient was sent to pacu in stable condition following the removal of the femoral sheaths.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2 and h11 has been updated.The complaint for regurgitation was unable to be confirmed due to unavailability of medical records and imagery.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu revealed no deficiencies.During the manufacturing process, all sapien xt 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, "a patient underwent a thv procedure with a 29mm sapien xt valve in pulmonic position.Approximately 7 years 11 months later, the patient presented with a failed valve due to pulmonic regurgitation with no clinically significant gradient." per the instructions for use (ifu), valve regurgitation, including paravalvular leak (pvl) and transvalvular leak (central), are known potential adverse events associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.Central regurgitation which develops progressively over time can be due to several issues including patient-related factors, structural valve deterioration (e.G.Calcification, leaflet thickening), and/or nonstructural dysfunction (fibrosis, pannus formation).Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Due to limited information, a definitive root cause was unable to be determined 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 XT
• Common Device Name: PULMONARY 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: 21283943
• Report Number: 2015691-2025-00625
• Device Sequence Number: 15399158
• Product Code: NPV
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)180922
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 09/22/2018
• Device Model 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2016
• 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: 43 YR
• Patient Sex: Male