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

Model Number 8300AB

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Regurgitation (2259)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis and/or regurgitation.Stenosis and/or regurgitation is most commonly related to patient factors, and is not usually an indication of a device malfunction.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 and/or procedural factors 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 pericardial aortic valve was disabled via a valve-in-valve procedure after an implant duration of 1 year, 7 months due to moderate-severe regurgitation, central regurgitation and moderate-to-severe paravalvular leak (pvl).A 23mm transcatheter valve was implanted along with vascular plugs.Pvl was reduced from moderate (post-transcatheter valve deployment) to mild.As reported the physician indicated the surgical valve did fail prematurely.

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: 9681584
• MDR Text Key: 178208955
• Report Number: 2015691-2020-10415
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: 8300AB
• Device Lot Number: R-17M6397
• 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: 64 YR