MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned from the implant patient registry that a model 11500a 19mm aortic valve was explanted and replaced with a 11500a 23mm valve after an implant duration of 2 years, 10 months due to unknown reasons.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

Event Description

It was learned from the implant patient registry and through medical record that a model 11500a 19mm aortic valve was explanted and replaced with a 11500a 23mm valve after an implant duration of 2 years, 10 months due to nonrheumatic mitral valve stenosis with insufficiency.Per pathology, the leaflets are mobile with no tears, calcifications, vegetations or perforations.Moderate pannus formation is identified.The patient tolerated the procedure well with no immediate complications and was discharged on pod# 5.Per medical record, the prosthetic aortic valve was excised, root enlarged with a pericardial patch that was brought up over the aorta as an aortic patch, mitral valve had mac that was debrided in order to fit a size 27 and also to be able to place valve stitches.A strip of felt was used to reinforce the posterior annulus.Tricuspid valve was dilated and so the surgeon repaired it with a tricuspid annuloplasty band.Echo report concludes that the left ventricle is normal in size.Left ventricular systolic function is normal.The right ventricle is normal in size.Right ventricular systolic function is normal.The left atrial cavity is severely dilated.There is moderate (2+ - 3+) mitral valve regurgitation due to restricted leaflet motion.Regurgitant orifice area (pisa) is 0.32 cm2.There is moderate mitral stenosis caused by calcification - annular.The peak gradient is 21 mmhg and the mean gradient is 7 mmhg.Visually ms may be more significant, mod-severe range.Mv gradients obtained at hr of 71 bpm.There is moderate (2+) tricuspid valve regurgitation lnspiris prosthetic aortic valve (size #19).There is no aortic valve regurgitation.The peak gradient is 35 mmhg, the mean gradient is 20 mmhg and the dimensionless valve index is 0.48.

Manufacturer Narrative

Updated sections: b4, b5, b7, g3, g6, h2, h6 (component code, clinical code, device code, and type of investigation).

Manufacturer Narrative

The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Engineering evaluation summary: per drm (b)(4), rev d, patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.The most likely cause is procedural factors.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was learned from the implant patient registry and through medical record that a model 11500a 19mm aortic valve was explanted after an implant duration of 2 years, 10 months due to patient prosthetic mismatch, with stenosis and pannus.The valve was replaced with a 23mm 11500a aortic valve.The patient tolerated the procedure well with no immediate complications and was discharged on pod# 5.Per medical record, pre op ct showed evidence of aortic valve leaflet calcification.Pre op echo showed no aortic regurgitation, the mean aortic gradient is 20mm hg with a peak gradient of 35mmhg.The prosthetic aortic valve was excised, the aortic root enlarged with a pericardial patch that was brought up over the aorta as an aortic patch.The patient underwent concomitant mvr with a 27mm mitris valve and tv repair with an edwards mc3 tricuspid annuloplasty band.It is noted in finding the patient had patient prosthetic mismatch of the aortic valve.Pathology showed the explanted aortic valve leaflets are mobile with no tears, calcifications, vegetations or perforations.Moderate pannus formation is identified.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17466907
• MDR Text Key: 320471990
• Report Number: 2015691-2023-15069
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)220725(11)170726215609705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2017
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female