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

Model Number 11500A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Aneurysm (1708); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was reported to be unavailable.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration and/or endocarditis.The cause of the event cannot be determined.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.

Event Description

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.Edwards implant patient registry received information a 25mm aortic valve was explanted after two (2) years, six (6) months, due to unknown reasons.The explanted device was replaced with a 29mm aortic valve.

Event Description

Edwards received information a 25mm aortic valve was explanted after an unknown implant duration due to unknown reasons.The explanted device was replaced with a non-edwards mechanical valve.Patient was discharged.

Manufacturer Narrative

Corrected data: corrected b5 and remove date from d6b as date of explant remains unknown.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Host tissue is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.Since the mechanism of host tissue growth in bioprosthetic heart valves is still not fully understood, the root cause for the host tissue growth for this particular valve cannot be determined at this time.Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) is the most common reason for bioprostheses explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.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 functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Stenosis, 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.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.The cause of the event was due to patient factors/conditions.

Event Description

Edwards implant patient registry received information a 25mm aortic valve was explanted after one (1) year, six (6) months due to aortic stenosis, degeneration, high gradient, insufficiency, small tear on one leaflet at the central part of the valve, dehiscence, and paravalvular leak.Patient presented with heart failure.There was a small tear in the central portion of the non coronary leaflet that resulted in mild regurgitation.The main problem was that there was chronic granulation tissue around the circumference of the annulus, particularly under the right coronary artery and extending into the noncoronary cusp where the sutures had totally dehisced, creating a large paravalvular leak and rocking of the valve and a very stable bioprosthesis.The explanted device was replaced with a non-edwards mechanical valve.The patient was taken to the intensive care unit in good condition with stable vital signs.Patient was discharged on post-operative day 10.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11914603
• MDR Text Key: 253761642
• Report Number: 2015691-2021-03257
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 122