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

Model Number 9600TFX29A

Device Problems Degraded (1153); Difficult to Open or Close (2921)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted.

Event Description

As reported by a field clinical specialist, a 29 mm sapien 3 valve was successfully implanted in a mitral surgical valve via transseptal approach.Approximately 2 years and 2 months post tmvr the patient was symptomatic with heart failure with reduced ejection fraction, heart failure iv symptom and severe pulmonary hypertension.The 29 mm sapien 3 valve was found to have stenosis.The patient was on eliquis and was transitioned to warfarin.Approximately 2 months later an echocardiogram reported an s3 mitral valve peak gradient of 47mm hg and mean gradient of 28mm hg.The velocity was 2.55m/sec and valve area was 0.6cm2 with severely reduced leaflet mobility and severe leaflet thickening.There was no significant regurgitation, thrombosis or vegetation.A 26 mm sapien 3 ultra was successfully implanted in the 29 mm sapien 3 in a valve-in-valve-in-valve procedure.Per the valve clinic coordinator, the perceived root cause of the stenosis was degeneration versus mitral valve thrombosis.

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 complaints for ''post-implantation - leaflet thickened/halt,'' ''post-implantation - leaflet motion restricted-in patient,'' and ''post-implantation - stenosis'' were unable to be confirmed due to unavailability of applicable medical record/imagery.A review of dhr did not identify any manufacturing non-conformances that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.During the manufacturing process, all sapien s3 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 contributed to the event.As reported, ''approximately 2 years and 2 months post tmvr the patient was symptomatic with heart failure with reduced ejection fraction, heart failure iv symptom and severe pulmonary hypertension.The 29 mm sapien 3 valve was found to have stenosis.The patient was on eliquis and was transitioned to warfarin.Approximately 2 months later an echocardiogram reported an s3 mitral valve peak gradient of 47mm hg and mean gradient of 28mm hg.The velocity was 2.55m/sec and valve area was 0.6cm2 with severely reduced leaflet mobility and severe leaflet thickening.There was no significant regurgitation, thrombosis or vegetation.'' per the instruction for use (ifu), leaflet thickening is a potential risk associated with bioprosthetic heart valves.Thickened leaflets may be caused by several patient-related factors including early valve deterioration (svd) (e.G.Calcification), non-structural dysfunction (e.G.Pannus), thrombosis (formation of blood clots on the valve) or endocarditis (bacterial inflammation).In this case, additionally provided information disclosed that patient had a history of hyperlipidemia, which is a known risk factor for bioprosthetic tissue calcification due to elevated cholesterol levels being implicated in the vascular calcification process.Calcium deposits can cause leaflet thickening over time.As such, available information suggests that patient factors (hyperlipidemia) may have contributed to the reported leaflet thickening.In this case, the thv leaflets likely became thickened from progressive calcification (due to hyperlipidemia as the underlying contributor), which could have impacted proper leaflet coaptation by restricting their motion.As such, available information suggests that patient factors (thickened leaflets) may have contributed to the reported leaflet motion restriction.Per the instruction for use (ifu), structural valve deterioration (stenosis) is a potential risk associated with bioprosthetic heart valves.In this case, it was reported that the leaflet was severely thickened with significant reduction in leaflet mobility.These factors can reduce the effective valve area resulting in stenosis.As such, available information suggests that patient factors (thickened leaflets, restricted leaflet) may have contributed to the reported stenosis.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: PROSTHESIS, MITRAL VALVE, 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: 16456864
• MDR Text Key: 310406475
• Report Number: 2015691-2023-11158
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)220129
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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 Age: 65 YR
• Patient Sex: Male