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

Model Number 9750TFX26A

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/25/2022

Event Type  Injury  

Event Description

As reported, approximately 7months post implant of a 26mm sapien 3 ultra in the aortic position via transcarotid approach, the valve presented with moderate to severe central aortic insufficiency from a frozen leaflet in the open position.A transcatheter heart valve (thv) in thv was done with great result for the patient.

Manufacturer Narrative

Investigation is ongoing.Device remains in patient.

Manufacturer Narrative

H6 updated.The valve was not returned; therefore, a visual inspection, functional testing, or dimensional testing was not performed.No imagery returned, therefore no imaging evaluation.As the complaints for post implantation central regurgitation and post implantation leaflet motion restricted in patient were unable to be confirmed, a lot history and complaint history review was not performed.No device was returned and there is no evidence to support a manufacturing/design defect potentially contributing to the complaint, therefore a manufacturing mitigation review is not required.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.The following instructions for use (ifu) were reviewed: edwards sapien 3/ sapien 3 ultra thv system, device preparation manual, and procedural training manual.Based on this review, no ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.No evidence of product nonconformances or labeling/ifu inadequacies were identified.The complaints for post implantation central regurgitation and post implantation leaflet motion restricted in patient were unable to be confirmed since relevant imagery or medical record was not provided for evaluation.A review of the dhr did not provide any indication that a manufacturing nonconformance contributed to the complaint event.A review of the ifu and training manuals 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, approximately 7months post implant of a 26mm sapien 3 ultra in the aortic position via transcarotid approach, patient appeared with a failed valve due to moderate to severe central aortic insufficiency.A transcatheter heart valve (thv) in thv was done with great result for the patient.The cause of moderate to severe central aortic insufficiency was a frozen leaflet in the open position.Review of post implantation leaflet motion restricted in patient attachments revealed that the during valve deployment, 2cc of additional volume was used during the initial valve deployment.Per the training manual, the delivery system requires a prescribed volume for thv deployment and proper function.In this case, it is possible that the use of additional volume during valve deployment may have over stretched the leaflet, which could have worsened over time leading to the reported moderate severe central regurgitation.As such, available information suggests that procedural factors (overexpanded valve) may have contributed to the reported event.Review of post implantation central regurgitation complaint activities indicate that, as reported, the cause of the central aortic insufficiency was a frozen leaflet in open position.Additionally, the leaflet motion restricted was possible due to the overexpanded valve.Restricted motion or improper functionality/coaptation of valve leaflets result in central regurgitation.As such, available information suggests that procedural factors (leaflet motion restricted motion due overexpanded valve) may have contributed to the reported event.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions (capa) are required.Since no product non conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation is not 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: 14478960
• MDR Text Key: 293473404
• Report Number: 2015691-2022-05813
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230510
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: No
• 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