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

Model Number 9600TFX29

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2021

Event Type  Injury  

Event Description

As reported by our affiliates in (b)(6), the patient who underwent an implant of a 29mm sapien 3 valve, in pulmonic position, by transfemoral approach required a valve in valve procedure due to degeneration of the valve.

Manufacturer Narrative

The valve remains implanted.Investigation is ongoing.

Manufacturer Narrative

As the valve remains implanted, a no product returned engineering evaluation was performed.As the device was not returned, no visual inspection, function testing or dimensional testing could be performed.No imagery was provided for review.Review of the work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.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.Since no product non-conformance were identified, a product risk assessment (pra) escalation is not required.Since no edwards defect was identified, no corrective or preventative actions are required.Device degeneration is a known potential risk associated with the tavr procedure and is listed in the instructions for use (ifu) as a potential adverse event.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd 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 the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.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, complaint was unable to be confirmed due to device unavailability/imagery unavailability.Based on the limited information provided, the root cause for the valve degeneration approximately 3 years 4 months post valve implant could not be determined but may be related to the patient's co-morbidities and/or progression of the pre-existing valvular disease process (carcinoid syndrome).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 our affiliates in italy, the patient who underwent an implant of a 29mm sapien 3 valve, in pulmonic position, by transfemoral approach required a valve in valve procedure due to degeneration of the valve.The physician confirmed the cause of the degeneration was regurgitation due to leaflet fibrosis in carcinoid syndrome.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: 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: 13043446
• MDR Text Key: 284188796
• Report Number: 2015691-2021-06923
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2018
• 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: 63 YR
• Patient Sex: Male