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

Model Number 9600TFX26A

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted.

Event Description

As reported by a field clinical specialist post tavr procedure with a 26mm sapien 3 valve in the aortic position, the valve failed due to stenosis.A 26mm sapien 3 ultra resilia was successfully implanted in a valve in valve procedure.The valve serial number is unknown at this time.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following section of this report has been updated: b4, g3, g6, h2, and h6.The device was not returned therefore, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The complaint for ''post-implantation - stenosis'' was unable to be confirmed due to unavailability of medical record/relevant imagery.Due to unavailability of valve serial number, dhr review was unable to be performed to determine if a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 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, ''post tavr procedure with a 26mm sapien 3 valve in the aortic position, the valve failed due to stenosis.A 26mm sapien 3 ultra resilia was successfully implanted in a valve in valve procedure''.Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.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 limited information, a definitive root cause was unable to be determined.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.Therefore, no corrective or preventative actions nor product risk assessment (pra) is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 16436839
• MDR Text Key: 310163630
• Report Number: 2015691-2023-11050
• Device Sequence Number: 1
• Product Code: NPT
• 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: 04/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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