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

Model Number 11500A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Congestive Heart Failure (1783); Hemorrhage/Bleeding (1888); Heart Failure (2206)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) 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.The clinical observation was confirmed through receipt of medical records.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 cannot be determined; however, patient factors and patient's underlying valvular disease pathology may have contributed to the 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.

Event Description

Edwards received information a patient with a 21mm aortic valve implanted 11 months, 21 days, underwent valve-in-valve procedure due to severe symptomatic nonrheumatic degenerative aortic stenosis, aortic valve insufficiency, perivalvular leak (pvl), and heart failure (new york heart associate class iii-iv).A 26mm non-edwards corevalve transcatheter valve was implanted inside the 21mm valve.The transesophageal echocardiogram indicated still evidence of perivalvular leak (pvl); however, initial aortogram which was inside the of the valve, indicated no leak through the valve itself.There was evidence that there was still a leak most likely pvl from the prosthetic surgical valve and subsequently transcatheter valve was post dilated with a 21mm true valve that that improved the pvl somewhat and subsequently a 22mm balloon was used as well.Patient remained hemodynamically stable.Overall, the patient tolerated procedure well without any complication.Transcatheter valve replacement of the previously placed surgical valve for valve failure producing improvement in pvl from severe to mild.Patient was discharged home on post-operative day two.It was learned the valve-in-valve was unsuccessful in treating the pvl so patient would be going in for a plug closure.

Manufacturer Narrative

H10.Additional manufacturer narrative: added h6 result code and conclusion code.H11.Corrected data: previously reported 4310 conclusion code is not applicable.

Manufacturer Narrative

H11.Corrected data: after re-review of the information b5 was revised with correct event detail.F10 codes applicable for this event are 1783 and 1457.Removed f10 codes 1717, 1716, 1153, 1250, and 1270.

Event Description

Edwards received information a patient with a 21mm aortic valve implanted 11 months, 21 days, underwent valve-in-valve procedure due to severe perivalvular leak (pvl), and heart failure (new york heart associate class iii-iv).A 26mm non-edwards corevalve transcatheter valve was implanted inside the 21mm valve.The transesophageal echocardiogram indicated still evidence of perivalvular leak (pvl); however, initial aortogram which was inside the of the valve, indicated no leak through the valve itself.There was evidence that there was still a leak most likely pvl from the prosthetic surgical valve and subsequently transcatheter valve was post dilated with a 21mm true valve that that improved the pvl somewhat and subsequently a 22mm balloon was used as well.Patient remained hemodynamically stable.Overall, the patient tolerated procedure well without any complication.Transcatheter valve replacement of the previously placed surgical valve for valve failure producing improvement in pvl from severe to mild.Patient was discharged home on post-operative day two.It was learned the valve-in-valve was unsuccessful in treating the pvl so patient would be going in for a plug closure.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10133193
• MDR Text Key: 194614936
• Report Number: 2015691-2020-12111
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: 11500A
• 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; Life Threatening; Required Intervention
• Patient Age: 74 YR