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

Model Number 11500A21

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

Patient Problems Aortic Regurgitation (1716); Hemorrhage/Bleeding (1888)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure and do not lead to serious injury or death.Acute central leaks observed in the peri-operative period usually occur from technique related issues, such as valve distortion during implant which may result in a dropped leaflet or asymmetric coaptation.These techniques are not typically the result of product malfunction; however.They may contribute to mild to severe regurgitation and if undetected may require reoperation.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons, such as technique and/or anatomical related reasons.In this case, as per echo review, although the submitted images are not sufficient to definitively determine the jet origin, both jet eccentricity and the suggestion of a flow convergence zone outside the sewing ring suggest the possibility of a paravalvular jet origin.The reported event cannot be confirmed with the available information.Product evaluation is still pending and a supplemental report will be submitted once completed.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.

Event Description

Edwards received notification that a 21mm aortic valve was explanted after an implant duration of 13 days due to moderate to severe (3+/4) intra-prosthetic insufficiency noted on echo at 3 days post-op.As reported, the initial implant was done with regular surgical technique with no issue during implantation.Per surgeon's opinion, the anesthesiologist did not perform a thorough evaluation intra-op and the leak was already present from the beginning.No issues were observed with the aortotomy prolene nor with the valve sutures.The right coronary leaflet seemed to be too ¿tense¿ in comparison with the two other leaflets, creating an area for a leak.The valve was replaced with another 21-mm valve.As the annulus margins were damaged with the removal of the inspiris, a pericardium patch was used to repair the annulus.As reported, the patient suffered seizure/convulsion a few hours after the explant/implant surgery and had to be reintubated, no brain damage has been observed.The explanted valve was returned for evaluation.The surgeon believes that on explant, while going through the prosthesis to capture the pledgets, he may have damaged the valve further.

Manufacturer Narrative

Product evaluation: customer report of insufficiency could not be confirmed through visual observations.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Minimal fibrin-like material encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 2 on the outflow aspect.Minimal fibrin-like material was also observed on the valve stent circumference on both the inflow and outflow aspects.A suture remained attached to the sewing ring around commissure 1.Valve will be sent to r&d for functional evaluation.No fibrin-like material could be seen from the provided photos of valve before explant.

Event Description

Edwards received notification that a 21mm aortic valve was explanted after an implant duration of 13 days due to moderate to severe (3+/4) intra-prosthetic insufficiency noted on echo at 3 days post-op.As reported, the initial implant was done with regular surgical technique with no issue during implantation.Per surgeon's opinion, the anesthesiologist did not perform a thorough evaluation intra-op and the leak was already present from the beginning.No issues were observed with the aortotomy, prolene nor with the valve sutures.The right coronary leaflet seemed to be too ¿tense¿ in comparison with the two other leaflets, creating an area for a leak.The valve was replaced with another 21mm valve.As the annulus margins were damaged with the removal of the alleged valve, a pericardium patch was used to repair the annulus.As reported, the patient suffered seizure/convulsion a few hours after the explant/implant surgery and had to be reintubated, no brain damage has been observed.The explanted valve was returned for evaluation.The surgeon believes that on explant, while going through the prosthesis to capture the pledgets, he may have damaged the valve further.As per echo review, the appearance and motion of the bioprosthesis leaflets are normal.Although the submitted images are not sufficient to definitively determine the jet origin, both jet eccentricity and the suggestion of a flow convergence zone outside the sewing ring suggest the possibility of a paravalvular jet origin.

Manufacturer Narrative

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.

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: 9442892
• MDR Text Key: 170852219
• Report Number: 2015691-2019-04572
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: 11500A21
• Device Lot Number: R-19C1645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 02/12/2020; 07/23/2020
• Supplement Dates FDA Received: 12/20/2019; 02/13/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR