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

Model Number 9000TFX23A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported by a field clinical specialist (fcs), approximately 10 years and 11 months post-implant of a 23 mm sapien valve in the aortic valve via transfemoral approach, the patient has ai regurgitation.The patient had valve in valve with a 23 sapien 3 ultra.The patient was transferred to recovery room.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected investigation conclusions and investigation findings.Added new information to b.1 report type and h.6 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.Valve regurgitation is a known risk associated with the use of the sapien valve.There is no indication that a design or manufacturing problem contributed to the event occurring after a 5-year implant duration.The complaint was unable to be confirmed due to unavailability of device, imagery and/or medical report.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.In this case, ''approximately 10 years and 11 months post-implant of a 23 mm sapien valve in the aortic valve via transfemoral approach, the patient has ai regurgitation.'' per the instructions for use (ifu), valve regurgitation is known potential adverse events associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.Regurgitation which develops progressively over time can be due to several issues including patient-related factors or structural valve deterioration, such as calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with the functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Due to insufficient information provided, the root cause cannot 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: EDWARDS SAPIEN 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: 16397783
• MDR Text Key: 309887054
• Report Number: 2015691-2023-10915
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2013
• Device Model Number: 9000TFX23A
• 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: 11/18/2011
• 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 Sex: Female