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

Model Number 9000TFX26A

Device Problem Calcified (1077)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore no dhr is required.A review of clinical literature was conducted and summarized.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to subsequent anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.There was no allegation of a device malfunction that caused or contributed to the event.The root cause of the event was likely due to patient related factors and the progression of the underly valvular disease pathology.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

Edwards received notification from a field clinical specialist that this patient underwent a tavr in tavr procedure.The original sapien 26mm valve was implanted for 7 years and 4 months failed due to calcification, as, and ai.The physicians did not feel this was an early failure of the first tavr valve.The tavr in tavr performed with no complications.The patient was discharged on pod#2.Per medical records, tee showed that the valve had an elevated mean gradient of 41mmhg with mild ar, moderately calcified with severe ai and stenosis.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: rene dorne ; 1 edwards way; linc 4-1; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11219747
• MDR Text Key: 228408910
• Report Number: 2015691-2021-00236
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2014
• Device Model Number: 9000TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2020
• Date Device Manufactured: 12/10/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR