MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problems Calcified (1077); Mechanical Problem (1384); Structural Problem (2506); Material Deformation (2976)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Regurgitation (2259); Stenosis (2263)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Calcification is a well-recognized failure mode of bioprosthetic valves.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), and mechanical stress related to the valve's hemodynamic performance.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.Although patient factors are believed to play a crucial role in the development in bioprosthetic tissue calcification, the underline mechanism is still not fully understood.The device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Udi number: (b)(4).

Event Description

It was reported that a 23mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 2 years due to degeneration, severe stenosis, regurgitation, leaflet thickening, leaflet motion restricted, and calcification.A non-edwards transcatheter valve was implanted.Patient was discharged on pod #1.

Manufacturer Narrative

Correction: the g4 date on the initial mdr for the initial aware date should be (b)(6) 2020.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa: 20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9831993
• MDR Text Key: 190957362
• Report Number: 2015691-2020-10961
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: 8300AB
• Device Lot Number: R-17H4735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR