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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Central Regurgitation (4068)

Patient Problems Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/27/2023

Event Type  Injury  

Event Description

It was reported that a patient with an edwards aortic valve, implanted in the pulmonic position, has been placed under evaluation for a valve-in-valve after an implant duration of less than 1 year due to moderate regurgitation.

Manufacturer Narrative

H10: additional manufacturer narrative: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.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.

Manufacturer Narrative

Echo imaging impression: central (valvular) pr first is evident on the (b)(6) 2022 tte (presumably ~ 5 months post-operative) and appears progressive on the (b)(6) 2023 tte (presumably ~ 11 months post-operate).There is an increase in transpulmonic velocity and gradients on the (b)(6) 2023 tte compared to the previous 3 ttes.The cause of the higher velocity and gradients could be due to variability in spectral doppler sampling or the increased volume load associated with severe pr, although prosthetic pulmonic stenosis cannot be excluded.

Manufacturer Narrative

Bioprosthetic valve regurgitation and/or stenosis can be attributed to structural valve deterioration(svd) and/or nonstructural valve dysfunction (nsvd).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) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Nsvd is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nonstructural dysfunction refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.Valve distortion during implant.May result in a dropped leaflet or asymmetric coaptation.[this is] not typically the result of product malfunction; however, [this] may contribute to mild to severe regurgitation and if undetected may require reoperation.Based on the information available, a definitive root cause cannot be concluded but patient factors, including history of congenital heart disease (tetralogy of fallot) and implant position, could have contributed.An edwards device defect has not been confirmed.This event is confirmed based on echo imaging analysis.There is no evidence to suggest an edwards manufacturing defect.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.The subject device is not available for evaluation as it remains implanted in the patient.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.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.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that a patient with an 25mm 11500a aortic valve, implanted in the pulmonic position, has been placed under evaluation for a valve-in-valve after an implant duration of less than 1 year due to moderate regurgitation and increased gradients.The patient presented with heart heart failure and fatigue.The re-intervention procedure has not yet occurred.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 17375386
• MDR Text Key: 319548979
• Report Number: 2015691-2023-14774
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)260413(11)220414219246463
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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; Other
• Patient Age: 36 YR
• Patient Sex: Male