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

Model Number 11500A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Congestive Heart Failure (1783); Thrombosis (2100); Regurgitation (2259); Stenosis (2263)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.Echo imaging was received and reviewed by the edwards subject matter expert.Echo imaging impression: the submitted images suggest soft-tissue density thickening of the aortic bioprosthesis, with involvement of all three leaflets.The echocardiographic findings are compatible with thrombus or (infective or noninfective) vegetations.The submitted images do not include doppler interrogation for stenosis or regurgitation.It is not known whether the cited 60 mm hg gradient is a peak instantaneous gradient (suggesting moderate aortic stenosis) or a mean gradient (suggesting very severe aortic stenosis).Based on the submitted images, it is possible that some amount of outflow obstruction is due to the soft-tissue density material extending into the valve orifice, in addition to what appears to be mildly reduced leaflet opening.The distinction of thrombus from vegetation may rely on clinical factors as well as potential evidence of leaflet destruction that might be seen in some cases of infective prosthetic valve endocarditis, and cannot be made solely based on the echocardiographic images.From a semantic standpoint, the diagnosis of hypoattenuated leaflet thickening (halt) is based on computed tomography, and potentially associated with a clinical diagnosis of subacute leaflet thrombosis.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve/ring.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.The clinical observation was confirmed.The cause of the event cannot be determined; however, patient factors 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 implanted with a 25mm aortic valve two (2) months was found to have aortic stenosis and regurgitation.All three (3) leaflets of the inspiris valve are thickened and showing reduced mobility like would be expected with hyper attenuated leaflet thickening (halt) with gradient of 60 mmhg.Plan is to place patient on warfarin to treat halt.There is no evidence of endocarditis, two sets of blood cultures off antibiotics are negative.Patient has been diagnosed with prostate cancer but not treated.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to a4, b5, b6, b7, d4, f10, h4, h6.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.

Event Description

Patient was noted to have chronic persistent atrial fibrillation and acute on chronic systolic congestive heart failure.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10283527
• MDR Text Key: 200054326
• Report Number: 2015691-2020-12534
• 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
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 78