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); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/28/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned for evaluation as it was discarded by the customer.Two pictures of the explanted valve were sent and reviewed.As per image evaluation, customer report of gradient increase and leaflet thickening was unable to be confirmed through image evaluation.Customer report of thrombus was confirmed through evaluation of the images provided.Pictures showed the outflow aspect of an explanted valve.What appeared to be vegetation was visible on the leaflets.Sewing ring was observed to be cut off around the valve.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.

Event Description

Edwards received notification that an inspiris resilia valve model 11500a25 was explanted after an implant duration of eight (8) months and twenty three (23) days due to valve thrombosis and leaflet thickening limiting the opening surface with gradient increase at 55 mmhg (mean gradient post operatively was 14 mmhg) and moderate regurgitation, with no signs of vegetation or abscess.Endocarditis was ruled out through multiple blood culture and serology which all resulted negative.The patient presented with nyha ii-iii dyspnea.An inspiris resilia valve model 11500a27 was implanted in replacement with no post operative complications except episode of flutter.Seven (7) months and twenty three (23) days after this avr the patient underwent a valve-in-valve procedure due to stenosis and regurgitation caused by a second valve thrombosis [medwatch #25507].

Manufacturer Narrative

Updated d4 (device expiration date) and h4 (device manufacturer date).Updated section b4 (date of this report), g3 (date received by manufacturer), h6 (health effect - clinical code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Corrected h6 (type of investigation), included "device discarded" instead of "device not accessible for testing" h10: additional manufacturer narrative: 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.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.In this case, the most likely cause is patient factors.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16276614
• MDR Text Key: 308526010
• Report Number: 2015691-2023-10473
• Device Sequence Number: 1
• Product Code: LWR
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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 Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG