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

Model Number 9000TFX26

Device Problem Calcified (1077)

Patient Problem Valvular Stenosis (2697)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.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.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes 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.It is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, the exact cause of the stenosis could not be confirmed.However, it is possible patient factors, (non-hodgkins lymphoma, radiation) may have contributed to the valve stenosis.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

Event Description

As reported by field clinical specialist (fcs), seven and a half years post implant of a sapien valve, a sapien 3 ultra valve was placed inside, due to stenosis.The patient was symptomatic.The patient had a valve in valve procedure performed.During valve deployment, the delivery system balloon burst.The system was removed without surgical intervention.Impella was placed to assist with hemodynamic compromise.While assessing valve function after implant, the patient was found to have a flailed mitral leaflet and severe mr.The cause is ultimately unknown.Physicians suspect the safari wire or the balloon during implant may have caused the mitral flail.Two days post implant of the second valve, the patient died.The cause of death was hemorrhagic stroke.It is not believed to have occurred during the procedure.

Manufacturer Narrative

Supplemental report to provide related manufacturer report no: 2015691-2021-02832 for the balloon burst.

• Brand Name: SAPIEN TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11772961
• MDR Text Key: 249098709
• Report Number: 2015691-2021-02791
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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 Expiration Date: 11/20/2014
• Device Model Number: 9000TFX26
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR