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

Model Number 9000TFX

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

The valve serial number, implant date and event date are unknown.The investigation is ongoing.The device remains implanted.

Event Description

Through the review of the medical article ''early experience with reverse double switch operation for the borderline left heart", corresponding author brandi braud scully, md, ms, eric n.Feins, md, wayne tworetzky, md, sunil ghelani, md, rebecca beroukhim, md, pedro j.Del nido, md, and sitaram m.Emani, md et al.The following event was identified: four years later the patient returned for transcatheter valve in valve mitral valve replacement for moderate to severe mitral regurgitation due to immobility of one of his sapien valve leaflets.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 component codes and type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were unable to be confirmed due to unavailability of the device, medical record, and imagery.As no valve serial number was provided, review of the dhr and lot history were unable to be performed.However, a review of the ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 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 complaint event.It should be noted that the sapien thv was implanted in the mitral position.The sapien thv system is indicated for a native aortic valve replacement only.Therefore, this was an off-label operation.As reported, ''four years later the patient returned for transcatheter valve in valve mitral valve replacement for moderate to severe mitral regurgitation due to immobility of one of his sapien valve leaflets.'' per the instructions for use (ifu), valve regurgitation is known potential adverse events associated with bioprosthetic heart valves and the tavr procedure.In this case, the restricted leaflet mobility likely led to improper coaptation of leaflets, resulting in the central regurgitation, as reported.Leaflet motion restriction develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Leaflet motion restriction may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.As such, available information suggests that patient factors (restricted leaflet motion) may have contributed to the reported to the regurgitation however, due to insufficient information provided, a definitive root cause for leaflet motion restriction is unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: 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: 18785144
• MDR Text Key: 336288729
• Report Number: 2015691-2024-01361
• 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: 04/18/2024

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: 9000TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention