MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL29A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the edwards field clinical specialist, approximately 3 days post tavr, a 2nd 29mm sapien 3 ultra resilia valve was successfully implanted in a 29mm s3ur due to moderate/severe central regurgitation and moderate paravalvular leak.The patient was stable and discharged home.Both central and pvl was resolved after 2nd valve.Per report, an additional 5ccs of fluid to the nominal prep volume was added and may have caused overexpansion resulting in leaflet damage.

Manufacturer Narrative

Update to h6 (type of investigation, investigation findings, and investigation conclusions) and h10 to reflect device evaluation.The event reported is an 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.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, 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.During the manufacturing process, all sapien 3 ultra resilia 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 complaint event.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.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, and valve under-sizing.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue due to 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.In this case, the central regurgitation and paravalvular leak were unable to be confirmed based on unavailability of imaging or medical report.The available information suggests (procedural factors - over expanded valve) may have contributed to the reported central regurgitation.A conclusive root cause was unable to be determined for the paravalvular leak.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 3 ULTRA RESILIA TRANSCATHETER HEART VALVE, 29MM
• 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: 18522771
• MDR Text Key: 332974347
• Report Number: 2015691-2024-00440
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260508(11)2305092110539363
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Model Number: 9755RSL29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/24/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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
• Patient Sex: Male